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INNO Implant System

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref AAR253Ref SAB535Ref IT4008SMRef SAC544Ref 2SMH6527Ref ISAC507Ref 2SBN551525Ref CSHH10SRef ISHR110Ref CSHN14SRef IENW536Ref CHW646Ref SAC514Ref HNW603Ref IPT3508SMRef IECR426Ref 2SBN752525Ref 2SMAN55304Ref 2SBH651535Ref SAB414Ref CHW626Ref 2SBH552535Ref ET3510SRef 2SBUN481517Ref 2SMN6527Ref ET4010SRef IONS403Ref 2SMH5527Ref AAR254Ref CHR546Ref IAAR158ARef IHCR020Ref IECW526Ref ET6012SRef CNR526Ref HNR503Ref SAB444Ref CHR526Ref SAC527Ref CHW636Ref 2SBN652525Ref CHW648Ref 2SBN451525Ref BSSB440Ref IPT4512SMRef 2SLCS200Ref IECW516Ref IPT5014SMRef 2SBH381527Ref CNW616Ref ET5007SRef IPT3510SMRef SAC537Ref IONS401Ref 2SBUH481527Ref THR001Ref 2STNA45CRef IASR055Ref 2SBN752545Ref 2SBH452525Ref EBAT514RRef CNR536Ref ISAB404Ref ISHR100Ref 2SMH6547Ref SAC444Ref IASR040Ref HNR506Ref SAB445Ref ET4514SRef 2SBN551535Ref ICVR001Ref SAC535Ref 2SLA440Ref ICVR002Ref CNW648Ref IPT4010SMRef IT4012SMRef GHW001NRef SAC424Ref 2SBH452545Ref IPT4014SMRef IT4007SMRef IHCW030Ref SAB527Ref ST4007SMRef HNR507Ref IHCR045Ref ISHR120Ref IPT6007SMRef IPT5010SMRef HNW602Ref IBAT404RRef 2SBN652535Ref 2SBUH481547Ref ET3512SRef SAB517Ref 2SBUN481545Ref ISAC505Ref HNW605Ref 2SMAN45303Ref CNW646Ref HNR505Ref 2BSSC001Ref IT4010SMRef SAB424Ref CHR538Ref 2SMN5547Ref 2SLHT40NRef CNW628Ref SAB544Ref 2SLA420Ref IPT5007SMRef SAB447Ref SAC437Ref IPT3512SMRef EBAT413RRef AAW254Ref SAC434Ref VNR001Ref EBAT414RRef CHR536Ref AAW153Ref IECR406Ref 2SBN651545Ref 2SBH752545Ref SHW100Ref 2STNA55CRef 2SMH4527Ref CNR516Ref 2SBUH481535Ref 2SBAT434RRef AAW253Ref IENW516Ref CSHN10SRef 2SBH651545Ref THW001Ref EBAT412RRef 2SBUH481525Ref 2SBUN481527Ref CNR546Ref 2SBN381527Ref IENR406Ref 2SBUS200Ref SAB524Ref IT4014SMRef 2SBUS300Ref 2SBAT454RRef 2SMPC45Ref 2SBH551535Ref CNW636Ref SAB417Ref 2SCCH45Ref SONS405Ref EBAT513RRef 2SBUN481525Ref SAB434Ref 2SBN452545Ref IT6010SMRef ET4512SRef IPT6010SMRef SAC425Ref AAW252Ref IENW526Ref SAC545Ref 2SBN751545Ref SAB415Ref IENR416Ref 2SLA410Ref IONS404Ref 2SBUH481517Ref SAC524Ref CHR528Ref ISAB405Ref IECR416Ref IPT4508SMRef 2SBN381537Ref IPT4007SMRef 2SBH381537Ref ISAB505Ref ET4507SRef ISAC407Ref HNW607Ref IGOW500NRef SLH425NRef IPT4507SMRef 2SMAH55155Ref 2SBH452535Ref IT4508SMRef ST5008SRef 2SCN6545Ref GNW001NRef 2HS4572Ref SAH45153NARef IT5014SMRef ST4014SMRef IAAR258ARef CNR548Ref SAB425Ref 2SBH551545Ref 2SCH6514Ref ISAB407Ref 2SCCH55Ref 2SAH45153Ref 2SAC6527Ref 2SMHT40HRef 2SMS453Ref 2SBH652535Ref 2SBUH481545Ref AAR152Ref 2SBH751545Ref 2SCH6544Ref IECR436Ref 2SAC6554Ref 2SBN651535Ref 2HS5542Ref 2SCH4517Ref 2SAN55253Ref 2HS4511Ref 2SBH552545Ref 2SMAH45152Ref VUHH7512Ref VUHN8672Ref 2SMN6547Ref EBAT411RRef SR338Ref IASR030Ref 2SAH45154BRef 2SMAH55304Ref 2SBN751525Ref IT4514SMRef 2SCN6557Ref IASR140Ref 2SLH515Ref ET4008SRef 2SCH6525Ref CHW638Ref 2SCN5554Ref 2SGH45NRef IHCW020Ref 2SSHR300Ref EBAT512RRef 2SCN4514Ref HNR502Ref ET6007SRef 2SAC4525Ref IHCR030Ref SCN4554NRef SCH4555NRef 2SBH752525Ref SONS406Ref AMCC001Ref VUHN6532Ref ET5010SRef 2SCN4544Ref SAB437Ref 2SAH55154Ref SR328Ref IASR130Ref 2SAC6514Ref IPT4514SMRef 2SCH4525Ref SAB534Ref 2ST4504SRef 2SCH4514Ref VUHH7552Ref IT3514SMRef 2SBH752535Ref SAB515Ref SAB537Ref ST4014SRef VNW001Ref ST5008SMRef ST5007SRef IASW140Ref 2HS5511Ref IENR426Ref 2SAH55252BRef 2SMS551

by Cowellmedi Co., Ltd.

Identity

Trade Name
INNO Implant System EUDAMED
INNO Submerged Implant System-Cemented Abutment FDA UDI
INNO SLA Submerged Narrow Implant System-Multi A Abutment FDA UDI
INNO SLA Submerged Implant System-Angulated Abutment FDA UDI
INNO SLA Submerged Implant System-Healing Abutment FDA UDI
INNO SLA Sub. Pre-Mount Fixture FDA UDI
INNO Submerged Implant System-Healing Abutment FDA UDI
INNO SLA Sub. Mount-Free Fixture FDA UDI
INNO Submerged Implant System-Absolute Abutment FDA UDI
INNO SLA Submerged Implant System-Sonator S Abutment FDA UDI
INNO SLA Submerged Narrow Implant System-Multi S Abutment FDA UDI
INNO SLA Submerged Narrow Implant System-Cemented Abutment(N) FDA UDI
Meta G UCLA Abutment-Meta G UCLA Abutment FDA UDI
INNO SLA Submerged Implant System-Shoulder Abutment Cap FDA UDI
INNO SLA Submerged Hybrid Ti-Base System-Hybrid L Ti-Base FDA UDI
INNO SLA Submerged Narrow Implant System-Straight Abutment FDA UDI
Mini Plus Implant System FDA UDI
INNO SLA Submerged Narrow Implant System-Multi Hybrid Ti Cylinder FDA UDI
INNO SLA Submerged Implant System-Abutment Screw FDA UDI
INNO SLA Submerged Narrow Implant System-Angulated Abutment(N) FDA UDI
Generic Name
Dental prosthesis/implant abutment screw FDA UDI
Dental implant suprastructure, permanent, preformed FDA UDI
Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Screw endosteal dental implant, two-piece FDA UDI
Screw endosteal dental implant, one-piece FDA UDI
Device Name
INNO Ext. Abutment EUDAMED
INNO Int. Fixture EUDAMED
INNO Sub. Abutment EUDAMED
INNO Int. Abutment EUDAMED
INNO Ext. Fixture EUDAMED
INNO Sub. Fixture EUDAMED
SONS405 EUDAMED
2SAH45153 EUDAMED
2SMS453 EUDAMED
2SCH4517 EUDAMED
2HS4511 EUDAMED
SONS406 EUDAMED
VUHN6532 EUDAMED
Model / Reference
AAR253 EUDAMED
SAB535 EUDAMED
IT4008SM EUDAMED
SAC544 EUDAMED
2SMH6527 EUDAMED
ISAC507 EUDAMED
2SBN551525 EUDAMED
CSHH10S EUDAMED
ISHR110 EUDAMED
CSHN14S EUDAMED
IENW536 EUDAMED
CHW646 EUDAMED
SAC514 EUDAMED
HNW603 EUDAMED
IPT3508SM EUDAMED
IECR426 EUDAMED
2SBN752525 EUDAMED
2SMAN55304 EUDAMEDFDA UDI
2SBH651535 EUDAMED
SAB414 EUDAMED
CHW626 EUDAMED
2SBH552535 EUDAMED
ET3510S EUDAMED
2SBUN481517 EUDAMED
2SMN6527 EUDAMED
ET4010S EUDAMED
IONS403 EUDAMED
2SMH5527 EUDAMED
AAR254 EUDAMED
CHR546 EUDAMED
IAAR158A EUDAMED
IHCR020 EUDAMED
IECW526 EUDAMED
ET6012S EUDAMED
CNR526 EUDAMED
HNR503 EUDAMED
SAB444 EUDAMED
CHR526 EUDAMED
SAC527 EUDAMED
CHW636 EUDAMED
2SBN652525 EUDAMED
CHW648 EUDAMED
2SBN451525 EUDAMED
BSSB440 EUDAMED
IPT4512SM EUDAMED
2SLCS200 EUDAMED
IECW516 EUDAMED
IPT5014SM EUDAMED
2SBH381527 EUDAMED
CNW616 EUDAMED
ET5007S EUDAMED
IPT3510SM EUDAMED
SAC537 EUDAMED
IONS401 EUDAMED
2SBUH481527 EUDAMED
THR001 EUDAMED
2STNA45C EUDAMED
IASR055 EUDAMED
2SBN752545 EUDAMED
2SBH452525 EUDAMED
EBAT514R EUDAMED
CNR536 EUDAMED
ISAB404 EUDAMED
ISHR100 EUDAMED
2SMH6547 EUDAMED
SAC444 EUDAMED
IASR040 EUDAMED
HNR506 EUDAMED
SAB445 EUDAMED
ET4514S EUDAMED
2SBN551535 EUDAMED
ICVR001 EUDAMED
SAC535 EUDAMED
2SLA440 EUDAMED
ICVR002 EUDAMED
CNW648 EUDAMED
IPT4010SM EUDAMED
IT4012SM EUDAMED
GHW001N EUDAMED
SAC424 EUDAMED
2SBH452545 EUDAMED
IPT4014SM EUDAMED
IT4007SM EUDAMED
IHCW030 EUDAMED
SAB527 EUDAMED
ST4007SM EUDAMED
HNR507 EUDAMED
IHCR045 EUDAMED
ISHR120 EUDAMED
IPT6007SM EUDAMED
IPT5010SM EUDAMED
HNW602 EUDAMED
IBAT404R EUDAMED
2SBN652535 EUDAMED
2SBUH481547 EUDAMED
ET3512S EUDAMED
SAB517 EUDAMED
2SBUN481545 EUDAMED
ISAC505 EUDAMED
HNW605 EUDAMED
2SMAN45303 EUDAMEDFDA UDI
CNW646 EUDAMED
HNR505 EUDAMED
2BSSC001 EUDAMED
IT4010SM EUDAMED
SAB424 EUDAMED
CHR538 EUDAMED
2SMN5547 EUDAMED
2SLHT40N EUDAMED
CNW628 EUDAMED
SAB544 EUDAMED
2SLA420 EUDAMED
IPT5007SM EUDAMED
SAB447 EUDAMED
SAC437 EUDAMED
IPT3512SM EUDAMED
EBAT413R EUDAMED
AAW254 EUDAMED
SAC434 EUDAMED
VNR001 EUDAMED
EBAT414R EUDAMED
CHR536 EUDAMED
AAW153 EUDAMED
IECR406 EUDAMED
2SBN651545 EUDAMED
2SBH752545 EUDAMED
SHW100 EUDAMED
2STNA55C EUDAMED
2SMH4527 EUDAMED
CNR516 EUDAMED
2SBUH481535 EUDAMED
2SBAT434R EUDAMED
AAW253 EUDAMED
IENW516 EUDAMED
CSHN10S EUDAMED
2SBH651545 EUDAMED
THW001 EUDAMED
EBAT412R EUDAMED
2SBUH481525 EUDAMED
2SBUN481527 EUDAMED
CNR546 EUDAMED
2SBN381527 EUDAMED
IENR406 EUDAMED
2SBUS200 EUDAMED
SAB524 EUDAMED
IT4014SM EUDAMED
2SBUS300 EUDAMED
2SBAT454R EUDAMED
2SMPC45 EUDAMED
2SBH551535 EUDAMED
CNW636 EUDAMED
SAB417 EUDAMED
2SCCH45 EUDAMED
SONS405 EUDAMEDFDA UDI
EBAT513R EUDAMED
2SBUN481525 EUDAMED
SAB434 EUDAMED
2SBN452545 EUDAMED
IT6010SM EUDAMED
ET4512S EUDAMED
IPT6010SM EUDAMED
SAC425 EUDAMED
AAW252 EUDAMED
IENW526 EUDAMED
SAC545 EUDAMED
2SBN751545 EUDAMED
SAB415 EUDAMED
IENR416 EUDAMED
2SLA410 EUDAMED
IONS404 EUDAMED
2SBUH481517 EUDAMED
SAC524 EUDAMED
CHR528 EUDAMED
ISAB405 EUDAMED
IECR416 EUDAMED
IPT4508SM EUDAMED
2SBN381537 EUDAMED
IPT4007SM EUDAMED
2SBH381537 EUDAMED
ISAB505 EUDAMED
ET4507S EUDAMED
ISAC407 EUDAMED
HNW607 EUDAMED
IGOW500N EUDAMED
SLH425N EUDAMED
2SCH4517 EUDAMEDFDA UDI
2SCH6544 EUDAMEDFDA UDI
2SMAH55155 EUDAMEDFDA UDI
2SAH45153 EUDAMEDFDA UDI
VUHH7552 EUDAMEDFDA UDI
ST4014S EUDAMEDFDA UDI
2SAH55154 EUDAMEDFDA UDI
2HS5542 EUDAMEDFDA UDI
ST5008SM EUDAMEDFDA UDI
2SAC6554 EUDAMEDFDA UDI
VUHH7512 EUDAMEDFDA UDI
2SCN4544 EUDAMEDFDA UDI
SONS406 EUDAMEDFDA UDI
2HS5511 EUDAMEDFDA UDI
2SAH55252B EUDAMEDFDA UDI
VUHN6532 EUDAMEDFDA UDI
2SMS453 EUDAMEDFDA UDI
SCN4554N EUDAMEDFDA UDI
2HS4511 EUDAMEDFDA UDI
ST5008S EUDAMEDFDA UDI
2SAC6527 EUDAMEDFDA UDI
2SCN6557 EUDAMEDFDA UDI
2SAH45154B EUDAMEDFDA UDI
2SCN6545 EUDAMEDFDA UDI
2SGH45N EUDAMEDFDA UDI
IASW140 EUDAMEDFDA UDI
VUHN8672 EUDAMEDFDA UDI
2SCH6525 EUDAMEDFDA UDI
2SAC4525 EUDAMEDFDA UDI
ST4014SM EUDAMEDFDA UDI
2SAN55253 EUDAMEDFDA UDI
2SCH6514 EUDAMEDFDA UDI
ST5007S EUDAMEDFDA UDI
2SCH4525 EUDAMEDFDA UDI
2SLH515 EUDAMEDFDA UDI
SR338 EUDAMEDFDA UDI
2SCH4514 EUDAMEDFDA UDI
2SMAH55304 EUDAMEDFDA UDI
AMCC001 EUDAMEDFDA UDI
IASR140 EUDAMEDFDA UDI
2SMHT40H EUDAMEDFDA UDI
2SMAH45152 EUDAMEDFDA UDI
2SMS551 EUDAMEDFDA UDI
2SSHR300 EUDAMEDFDA UDI
2SCN4514 EUDAMEDFDA UDI
SAH45153NA EUDAMEDFDA UDI
SCH4555N EUDAMEDFDA UDI
2SAC6514 EUDAMEDFDA UDI
2SCN5554 EUDAMEDFDA UDI
2HS4572 EUDAMEDFDA UDI
SR328 EUDAMEDFDA UDI
IPT4507SM EUDAMED
2SBH452535 EUDAMED
IT4508SM EUDAMED
GNW001N EUDAMED
IT5014SM EUDAMED
IAAR258A EUDAMED
CNR548 EUDAMED
SAB425 EUDAMED
2SBH551545 EUDAMED
ISAB407 EUDAMED
2SCCH55 EUDAMED
2SBH652535 EUDAMED
2SBUH481545 EUDAMED
AAR152 EUDAMED
2SBH751545 EUDAMED
IECR436 EUDAMED
2SBN651535 EUDAMED
2SBH552545 EUDAMED
2SMN6547 EUDAMED
EBAT411R EUDAMED
IASR030 EUDAMED
2SBN751525 EUDAMED
IT4514SM EUDAMED
ET4008S EUDAMED
CHW638 EUDAMED
IHCW020 EUDAMED
EBAT512R EUDAMED
HNR502 EUDAMED
ET6007S EUDAMED
IHCR030 EUDAMED
2SBH752525 EUDAMED
ET5010S EUDAMED
SAB437 EUDAMED
IASR130 EUDAMED
IPT4514SM EUDAMED
SAB534 EUDAMED
2ST4504S EUDAMED
IT3514SM EUDAMED
2SBH752535 EUDAMED
SAB515 EUDAMED
SAB537 EUDAMED
VNW001 EUDAMED
IENR426 EUDAMED

Identifiers

Primary DI / UDI-DI
08809471728558 EUDAMED
08809471729265 EUDAMED
08809471726844 EUDAMED
08809471728992 EUDAMED
08800016100938 EUDAMED
08809471727551 EUDAMED
08800016122794 EUDAMED
08800016103328 EUDAMED
08809471727292 EUDAMED
08800016103823 EUDAMED
08800016103267 EUDAMED
08809471728275 EUDAMED
08809471728961 EUDAMED
08809471728114 EUDAMED
08809471726561 EUDAMED
08809471727131 EUDAMED
08800016122428 EUDAMED
08800016100532 EUDAMEDFDA UDI
08800016121513 EUDAMED
08809471729081 EUDAMED
08809471728251 EUDAMED
08800016122619 EUDAMED
08809471727780 EUDAMED
08800016122015 EUDAMED
08800016100990 EUDAMED
08809471727834 EUDAMED
08800016105070 EUDAMED
08800016100914 EUDAMED
08809471728565 EUDAMED
08809471728190 EUDAMED
08809471727230 EUDAMED
08809471727056 EUDAMED
08809471727162 EUDAMED
08809471727995 EUDAMED
08809471728336 EUDAMED
08809471728053 EUDAMED
08809471729111 EUDAMED
08809471728176 EUDAMED
08809471729050 EUDAMED
08809471728268 EUDAMED
08800016122459 EUDAMED
08809471728312 EUDAMED
08800016122824 EUDAMED
08809471726301 EUDAMED
08809471726684 EUDAMED
08800016106305 EUDAMED
08809471727155 EUDAMED
08809471726745 EUDAMED
08800016122879 EUDAMED
08809471728404 EUDAMED
08800016103601 EUDAMED
08809471726578 EUDAMED
08809471729067 EUDAMED
08800016106008 EUDAMED
08800016122084 EUDAMED
08809471728602 EUDAMED
08800016101089 EUDAMED
08809471727421 EUDAMED
08800016119848 EUDAMED
08800016122657 EUDAMED
08800016112832 EUDAMED
08809471728343 EUDAMED
08809471727568 EUDAMED
08809471727308 EUDAMED
08800016100945 EUDAMED
08809471728879 EUDAMED
08809471727414 EUDAMED
08809471728084 EUDAMED
08809471729159 EUDAMED
08809471727902 EUDAMED
08800016122787 EUDAMED
08809471727025 EUDAMED
08809471729029 EUDAMED
08800016106275 EUDAMED
08809471727032 EUDAMED
08809471728473 EUDAMED
08809471726622 EUDAMED
08809471726868 EUDAMED
08809471728657 EUDAMED
08809471728855 EUDAMED
08800016122633 EUDAMED
08809471726646 EUDAMED
08800016103915 EUDAMED
08809471727094 EUDAMED
08809471729296 EUDAMED
08809471720446 EUDAMED
08809471728091 EUDAMED
08809471727070 EUDAMED
08809471727315 EUDAMED
08809471726752 EUDAMED
08809471726721 EUDAMED
08809471728107 EUDAMED
08800016108842 EUDAMED
08800016122442 EUDAMED
08800016122060 EUDAMED
08809471727797 EUDAMED
08809471729289 EUDAMED
08800016122022 EUDAMED
08809471727544 EUDAMED
08809471728138 EUDAMED
08800016100501 EUDAMEDFDA UDI
08809471728435 EUDAMED
08809471728077 EUDAMED
08809471726356 EUDAMED
08809471726851 EUDAMED
08809471729098 EUDAMED
08809471728220 EUDAMED
08800016100983 EUDAMED
08800016106299 EUDAMED
08809471728459 EUDAMED
08809471729234 EUDAMED
08800016106404 EUDAMED
08800016104691 EUDAMED
08809471729197 EUDAMED
08809471728947 EUDAMED
08809471726585 EUDAMED
08800016112788 EUDAMED
08809471728596 EUDAMED
08809471728862 EUDAMED
08809471728022 EUDAMED
08800016112795 EUDAMED
08809471728183 EUDAMED
08809471728527 EUDAMED
08809471727117 EUDAMED
08800016122749 EUDAMED
08800016122541 EUDAMED
08809471728732 EUDAMED
08800016101072 EUDAMED
08800016100891 EUDAMED
08809471728329 EUDAMED
08800016122114 EUDAMED
08800016104325 EUDAMED
08809471728589 EUDAMED
08809471727216 EUDAMED
08800016103311 EUDAMED
08800016122916 EUDAMED
08809471728619 EUDAMED
08800016112771 EUDAMED
08800016122121 EUDAMED
08800016122008 EUDAMED
08809471728350 EUDAMED
08800016122701 EUDAMED
08809471727179 EUDAMED
08800016122169 EUDAMED
08809471729210 EUDAMED
08809471726875 EUDAMED
08800016122152 EUDAMED
08800016104349 EUDAMED
08800016100686 EUDAMED
08800016121544 EUDAMED
08809471728428 EUDAMED
08809471729166 EUDAMED
08800016100716 EUDAMED
08800016104264 EUDAMEDFDA UDI
08800016112825 EUDAMED
08800016122046 EUDAMED
08809471729104 EUDAMED
08800016122497 EUDAMED
08809471727001 EUDAMED
08809471727896 EUDAMED
08809471726776 EUDAMED
08809471728893 EUDAMED
08809471728572 EUDAMED
08809471727223 EUDAMED
08809471729036 EUDAMED
08800016122718 EUDAMED
08809471729128 EUDAMED
08809471727186 EUDAMED
08800016106411 EUDAMED
08800016105087 EUDAMED
08800016122091 EUDAMED
08809471728978 EUDAMED
08809471728213 EUDAMED
08809471727575 EUDAMED
08809471727124 EUDAMED
08809471726660 EUDAMED
08800016122695 EUDAMED
08800016103922 EUDAMED
08800016122862 EUDAMED
08809471727605 EUDAMED
08800016103595 EUDAMED
08809471727520 EUDAMED
08809471728152 EUDAMED
08809471727261 EUDAMED
08800016105926 EUDAMED
08809471721184 EUDAMEDFDA UDI
08809471721412 EUDAMEDFDA UDI
08800016100570 EUDAMEDFDA UDI
08800016102079 EUDAMEDFDA UDI
08800016100051 EUDAMEDFDA UDI
08800016126211 EUDAMEDFDA UDI
08809471720293 EUDAMEDFDA UDI
08800016100143 EUDAMEDFDA UDI
08809471723478 EUDAMEDFDA UDI
08809471720132 EUDAMEDFDA UDI
08809471722327 EUDAMEDFDA UDI
08800016126259 EUDAMEDFDA UDI
08800016100549 EUDAMEDFDA UDI
08809471721566 EUDAMEDFDA UDI
08800016104271 EUDAMEDFDA UDI
08809471723447 EUDAMEDFDA UDI
08800016101331 EUDAMEDFDA UDI
08800016107470 EUDAMEDFDA UDI
08800016100426 EUDAMEDFDA UDI
08800016102840 EUDAMEDFDA UDI
08809471723386 EUDAMEDFDA UDI
08809471720361 EUDAMEDFDA UDI
08809471722396 EUDAMEDFDA UDI
08809471721979 EUDAMEDFDA UDI
08800016101232 EUDAMEDFDA UDI
08809471721917 EUDAMEDFDA UDI
08800016101034 EUDAMEDFDA UDI
08809471724369 EUDAMEDFDA UDI
08800016125986 EUDAMEDFDA UDI
08809471721443 EUDAMEDFDA UDI
08809471722044 EUDAMEDFDA UDI
08809471720088 EUDAMEDFDA UDI
08800016100334 EUDAMEDFDA UDI
08809471721382 EUDAMEDFDA UDI
08809471720354 EUDAMEDFDA UDI
08809471721146 EUDAMEDFDA UDI
08800016106176 EUDAMEDFDA UDI
08809471729975 EUDAMEDFDA UDI
08809471721085 EUDAMEDFDA UDI
08809471729685 EUDAMEDFDA UDI
08809471724338 EUDAMEDFDA UDI
08800016104912 EUDAMEDFDA UDI
08800016100457 EUDAMEDFDA UDI
08800016103168 EUDAMEDFDA UDI
08809471721535 EUDAMEDFDA UDI
08800016102499 EUDAMEDFDA UDI
08800016102642 EUDAMEDFDA UDI
08809471722280 EUDAMEDFDA UDI
08809471721726 EUDAMEDFDA UDI
08809471723430 EUDAMEDFDA UDI
08809471729968 EUDAMEDFDA UDI
08800016105933 EUDAMED
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08800016121537 EUDAMED
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Basic UDI-DI
B-08809471728558 EUDAMED
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B-08809471727223 EUDAMED
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B-08800016122718 EUDAMED
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B-08800016105926 EUDAMED
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B-08809471720361 EUDAMED
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B-08809471723430 EUDAMED
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B-08800016100723 EUDAMED
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B-08800016122602 EUDAMED
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B-08809471727407 EUDAMED
B-08800016101232 EUDAMED
B-08800016100549 EUDAMED
B-08800016122732 EUDAMED
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B-08809471721979 EUDAMED
B-08809471724338 EUDAMED
B-08800016106176 EUDAMED
B-08809471727827 EUDAMED
B-08809471721443 EUDAMED
B-08809471728305 EUDAMED
B-08809471721726 EUDAMED
B-08800016101034 EUDAMED
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B-08800016103168 EUDAMED
B-08800016112818 EUDAMED
B-08809471721535 EUDAMED
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B-08809471727964 EUDAMED
B-08809471722044 EUDAMED
B-08809471727063 EUDAMED
B-08800016102840 EUDAMED
B-08800016102642 EUDAMED
B-08800016122565 EUDAMED
B-08800016104271 EUDAMED
B-08809471729685 EUDAMED
B-08800016107470 EUDAMED
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B-08809471729180 EUDAMED
B-08800016100143 EUDAMED
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B-08800016112740 EUDAMED
B-08809471722280 EUDAMED
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B-08809471721146 EUDAMED
B-08809471729227 EUDAMED
B-08800016106633 EUDAMED
B-08809471721085 EUDAMED
B-08800016126211 EUDAMED
B-08809471726820 EUDAMED
B-08800016122558 EUDAMED
B-08809471729241 EUDAMED
B-08809471729302 EUDAMED
B-08809471720293 EUDAMED
B-08809471728039 EUDAMED
B-08809471720132 EUDAMED
B-08809471720354 EUDAMED
B-08809471724369 EUDAMED
B-08809471723447 EUDAMED
B-08809471727193 EUDAMED
B-08800016101331 EUDAMED
B-08800016100457 EUDAMED
510(k) Number
K132242 FDA UDI
K231395 FDA UDI
K201323 FDA UDI
K232546 FDA UDI
K231411 FDA UDI
K090049 FDA UDI
FDA Product Code
NHA FDA UDI
DZE FDA UDI
EMDN Code
P01020101 DENTAL IMPLANTS EUDAMED
GMDN Term
Dental prosthesis/implant abutment screw FDA UDI
Dental implant suprastructure, permanent, preformed FDA UDI
Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Screw endosteal dental implant, two-piece FDA UDI
Screw endosteal dental implant, one-piece FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
872.3640 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDIEUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDIEUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDIFDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDIFDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

INNO Implant System by Cowellmedi Co., Ltd — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cowellmedi Co., Ltd.
EUDAMED SRN
KR-MF-000009689
Authorised Representative
AR Experts B.V. NL-AR-000023989

Sources (334)

  • EUDAMED 044760ed-5c14-446a-ae22-963b26636670 61 fields · synced Sep 18, 2026
  • EUDAMED 22a24695-1ae2-435f-b8e3-3369b7ff6a59 61 fields · synced May 11, 2026
  • EUDAMED 3ce1b7f3-cdee-4e7e-bd60-b0b82b90690d 61 fields · synced May 11, 2026
  • EUDAMED 5fc732eb-1a06-4b57-967c-77328c6f5d52 61 fields · synced May 11, 2026
  • EUDAMED 66929312-7e60-41fa-b6c9-8d343fc8bf2d 61 fields · synced May 11, 2026
  • EUDAMED 847f9ac1-7666-4e80-95a2-0263a907050d 61 fields · synced May 11, 2026
  • EUDAMED 8cd7bb6e-c3dd-4d89-9927-dfebca936ca4 61 fields · synced May 11, 2026
  • EUDAMED 9eab4e07-7b4a-452c-87a4-b13ae7ff3f75 61 fields · synced May 11, 2026
  • EUDAMED 9fffd13c-648d-4969-ad98-b22c3e22c6fa 61 fields · synced May 11, 2026
  • EUDAMED e3d795cf-a65c-4254-94a4-6789a011f0d5 61 fields · synced May 11, 2026
  • EUDAMED ebbe644f-c8c4-4834-9dd2-679ecd1b1660 61 fields · synced May 11, 2026
  • EUDAMED ead6b2d3-54a5-4396-8c66-8071fd1dc425 61 fields · synced May 11, 2026
  • EUDAMED f31df145-706a-4507-a695-75e625662a9a 61 fields · synced May 11, 2026
  • EUDAMED f53a8a8b-113d-44e9-a005-3a28deb69907 61 fields · synced May 11, 2026
  • EUDAMED 0f53cc56-7550-4cb9-968e-7c56bdc1f052 61 fields · synced May 11, 2026
  • EUDAMED 1918d8d9-4bb5-484a-b4da-02726a4543e3 61 fields · synced May 11, 2026
  • EUDAMED 18b9b079-82aa-498c-b36a-03c5a49fd4f5 61 fields · synced May 11, 2026
  • EUDAMED ebc9f76c-bbbc-44a2-a0a9-61bfcf099471 61 fields · synced May 16, 2026
  • EUDAMED f1a5232d-43ea-43ee-a383-0da584a96bf2 61 fields · synced May 16, 2026
  • EUDAMED a7ed6ade-8c41-4251-8334-9edf01ffcd18 61 fields · synced May 16, 2026
  • EUDAMED 2af99840-6a6f-4cd0-8ba6-55711b075c97 61 fields · synced May 16, 2026
  • EUDAMED 39a88754-d6d4-4943-8e40-28cdf2a8230b 61 fields · synced May 16, 2026
  • EUDAMED 465ef132-d502-4e5a-9dfe-2fdbfb7fa92f 61 fields · synced May 16, 2026
  • EUDAMED 7d25703e-dce5-49e3-84e4-c3ca9a04133a 61 fields · synced May 16, 2026
  • EUDAMED f6f06df8-cd8b-43b5-a986-443e5742c2d5 61 fields · synced May 16, 2026
  • EUDAMED 4e724972-d406-4aca-a8f6-1a7683f66c8a 61 fields · synced May 16, 2026
  • EUDAMED d24c76cb-c6d8-4d92-a192-128b1ea73753 61 fields · synced May 16, 2026
  • EUDAMED 102cf760-ccea-4199-857b-8b822219074a 61 fields · synced May 16, 2026
  • EUDAMED f9982f39-0859-48f8-89d6-60407be53226 61 fields · synced May 16, 2026
  • EUDAMED 458da973-b048-4624-b1ca-7fc663f250f7 61 fields · synced May 16, 2026
  • EUDAMED 5863021a-0aef-4574-a4d0-10e5567ff104 61 fields · synced May 16, 2026
  • EUDAMED 9851b21b-db8c-44e2-a303-ee887137e685 61 fields · synced May 16, 2026
  • EUDAMED eabb1c9e-3139-4797-8a48-50f9e00c112f 61 fields · synced May 16, 2026
  • EUDAMED cf7ee832-d180-4d5e-a8a1-9558d0e7fc31 61 fields · synced May 16, 2026
  • EUDAMED 480acf69-defa-4cc9-b60c-b98cd6e3e15f 61 fields · synced May 16, 2026
  • EUDAMED 56659531-b888-4c37-ad13-376a52d67afd 61 fields · synced May 16, 2026
  • EUDAMED a500577c-6ea0-4ed8-b860-b4f2d71fd6c2 61 fields · synced May 16, 2026
  • EUDAMED 7ea487ff-ffd2-48cf-a5ea-24d86b51581a 61 fields · synced May 16, 2026
  • EUDAMED fcf87084-2ee7-48a2-b69f-1bf61c86041e 61 fields · synced May 16, 2026
  • EUDAMED 5c839248-ffc4-4bc1-8935-0984b7fe0910 61 fields · synced May 16, 2026
  • EUDAMED 76afdbc3-6379-4713-b882-6feca65e06b9 61 fields · synced May 16, 2026
  • EUDAMED a9ea0fd8-0706-426c-869d-49c9cb32acb6 61 fields · synced May 16, 2026
  • EUDAMED 91414f33-3d23-4e7c-8514-3f5d62780eb7 61 fields · synced May 16, 2026
  • EUDAMED 616952b4-d34c-4528-8a3a-aab1518868e8 61 fields · synced May 16, 2026
  • EUDAMED 81f0c105-7dea-4519-9dc4-ef280d3b63b9 61 fields · synced May 16, 2026
  • EUDAMED 432316f4-fb18-41a4-8b7f-89cd57d6a80e 61 fields · synced May 16, 2026
  • EUDAMED ffd69f8c-46b7-47a3-bbfb-b7815fddb8be 61 fields · synced May 17, 2026
  • EUDAMED 612aef44-82f2-4a32-ad23-3172cdb9d00c 61 fields · synced May 17, 2026
  • EUDAMED f297a2c8-a559-4e65-9bf7-e797885380e3 61 fields · synced May 17, 2026
  • EUDAMED ea500e2f-d3e0-4a34-86b6-b3bbae93a48f 61 fields · synced May 17, 2026
  • EUDAMED 0dd43d81-a8a8-45ec-b86d-e21f009e2ecb 61 fields · synced May 17, 2026
  • EUDAMED 03821993-96d8-4d52-8336-642380ff47ca 61 fields · synced May 17, 2026
  • EUDAMED 25fe4b58-dfbc-45b8-aaa6-e7cce0969328 61 fields · synced May 17, 2026
  • EUDAMED 056a024a-962a-4601-9638-dddee74b44cf 61 fields · synced May 17, 2026
  • EUDAMED 9f55a74e-2a14-4b2a-ba6f-053eb88fca9c 61 fields · synced May 17, 2026
  • EUDAMED d3b218ca-98a5-4ca0-80d9-7dc3ae34b6c2 61 fields · synced May 17, 2026
  • EUDAMED b3eb7300-8d0c-4e3b-9594-21aaae5fdde2 61 fields · synced May 17, 2026
  • EUDAMED bca04b86-8b78-448e-a075-69dd8dfc3715 61 fields · synced May 17, 2026
  • EUDAMED 1377d1d0-7ec3-4102-a4f2-d90e30550345 61 fields · synced May 17, 2026
  • EUDAMED 4af7ee7e-6721-45f7-935b-3529da9a4828 61 fields · synced May 17, 2026
  • EUDAMED 992693db-77b0-425a-b707-2158ea8a7915 61 fields · synced May 17, 2026
  • EUDAMED a2c86327-b8ae-4907-9eb5-3a3f0aafed1e 61 fields · synced May 17, 2026
  • EUDAMED d0c47c0d-1d93-4e5a-9ad7-9033f0f265c9 61 fields · synced May 17, 2026
  • EUDAMED 0be11901-0435-4acf-8fcd-106805c31d73 61 fields · synced May 17, 2026
  • EUDAMED 835762c4-b005-4875-8379-9af8731fbd39 61 fields · synced May 17, 2026
  • EUDAMED 64356994-2c3b-4c4d-8017-1c2915e1bd34 61 fields · synced May 17, 2026
  • EUDAMED f411bb88-2b86-44f2-956d-d7ebca217ffa 61 fields · synced May 17, 2026
  • EUDAMED 76db7bd7-255c-423d-bd45-8572eaa03eff 61 fields · synced May 17, 2026
  • EUDAMED e88a8104-aeea-4fc0-b720-7989e0a7859e 61 fields · synced May 17, 2026
  • EUDAMED dceb6a7a-7fb0-498b-a8e9-da359633aecd 61 fields · synced May 17, 2026
  • EUDAMED 4e73ba1b-c633-4283-a68f-8a08c4e00f7d 61 fields · synced May 17, 2026
  • EUDAMED 5bb50b82-5d6c-4738-b96b-737b69084a26 61 fields · synced May 17, 2026
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