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Surgical Drill
EUDAMEDClass IIa (EU MDR)
Ref STS1815LModel IH IMPLANT SYSTEM Ref SGEA4310Ref SGEA3808Ref ST3008Ref ST3813Ref SGEA3307Ref ST5313Ref EAS3015SRef STS3315LRef ST2213Ref ST2710Ref EA3013Ref SP333810Ref EA5313Ref ST4310Ref SGEA4307Ref EAS3815LRef SPS4353SRef SP333813Ref SP223007Ref SGEA3313Ref EA3313Ref EAS4315SRef ST3307Ref EA3008Ref SGEA3308Ref SGEA3310Ref EA3310Ref SP303313Ref SP435311Ref EA3807Ref SPS3033LRef EAS3015LWRef ST2707Ref STS3315SWRef EA3307Ref EA4310Ref SPS2230LRef ST2211Ref ST3007Ref SP303311Ref ST3010Ref EA4311Ref SPS4353LRef EA3813Ref STS3815SRef TS3D3317Ref SGEA3011Ref ST4308Ref ST3807Ref TS3D4317Ref STS2215LRef ST3011Ref STS5315SRef STS4315SRef STS3315SRef FD5013Ref SP435313Ref SP303307Ref EA5311Ref STS3015LRef STS2215SRef SP223011Ref ST4311Ref STS2715LRef ST3808Ref ST3308Ref SGEA3311Ref ST3311Ref TS2D2217Ref ST2210Ref STS1815SRef SP384307Ref SP384313Ref EA3011Ref SGST2210Ref SGEA3807Ref EA5310Ref SPS3033SRef ST3810Ref EA3010Ref EA3808Ref SP384311Ref ST5310Ref SP384310Ref SPS3338SRef ST4313Model IH IMPLANT SYSTEMRef SP223010Ref EAS5315SRef SP435308Ref STS2215SWRef ST3313Ref ST3811Ref FD5513Ref EAS4315LRef SGEA3007Ref SPS3338LRef SGEA3810Ref ST5311Ref SGEA3813
Identity
- Trade Name
- Surgical Drill EUDAMED
- Device Name
- Surgical Drill EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDSTS1815L EUDAMEDSGEA4310 EUDAMEDSGEA3808 EUDAMEDST3008 EUDAMEDST3813 EUDAMEDSGEA3307 EUDAMEDST5313 EUDAMEDEAS3015S EUDAMEDSTS3315L EUDAMEDST2213 EUDAMEDST2710 EUDAMEDEA3013 EUDAMEDSP333810 EUDAMEDEA5313 EUDAMEDST4310 EUDAMEDSGEA4307 EUDAMEDEAS3815L EUDAMEDSPS4353S EUDAMEDSP333813 EUDAMEDSP223007 EUDAMEDSGEA3313 EUDAMEDEA3313 EUDAMEDEAS4315S EUDAMEDST3307 EUDAMEDEA3008 EUDAMEDSGEA3308 EUDAMEDSGEA3310 EUDAMEDEA3310 EUDAMEDSP303313 EUDAMEDSP435311 EUDAMEDEA3807 EUDAMEDSPS3033L EUDAMEDEAS3015LW EUDAMEDST2707 EUDAMEDSTS3315SW EUDAMEDEA3307 EUDAMEDEA4310 EUDAMEDSPS2230L EUDAMEDST2211 EUDAMEDST3007 EUDAMEDSP303311 EUDAMEDST3010 EUDAMEDEA4311 EUDAMEDSPS4353L EUDAMEDEA3813 EUDAMEDSTS3815S EUDAMEDTS3D3317 EUDAMEDSGEA3011 EUDAMEDST4308 EUDAMEDST3807 EUDAMEDTS3D4317 EUDAMEDSTS2215L EUDAMEDST3011 EUDAMEDSTS5315S EUDAMEDSTS4315S EUDAMEDSTS3315S EUDAMEDFD5013 EUDAMEDSP435313 EUDAMEDSP303307 EUDAMEDEA5311 EUDAMEDSTS3015L EUDAMEDSTS2215S EUDAMEDSP223011 EUDAMEDST4311 EUDAMEDSTS2715L EUDAMEDST3808 EUDAMEDST3308 EUDAMEDSGEA3311 EUDAMEDST3311 EUDAMEDTS2D2217 EUDAMEDST2210 EUDAMEDSTS1815S EUDAMEDSP384307 EUDAMEDSP384313 EUDAMEDEA3011 EUDAMEDSGST2210 EUDAMEDSGEA3807 EUDAMEDEA5310 EUDAMEDSPS3033S EUDAMEDST3810 EUDAMEDEA3010 EUDAMEDEA3808 EUDAMEDSP384311 EUDAMEDST5310 EUDAMEDSP384310 EUDAMEDSPS3338S EUDAMEDST4313 EUDAMEDSP223010 EUDAMEDEAS5315S EUDAMEDSP435308 EUDAMEDSTS2215SW EUDAMEDST3313 EUDAMEDST3811 EUDAMEDFD5513 EUDAMEDEAS4315L EUDAMEDSGEA3007 EUDAMEDSPS3338L EUDAMEDSGEA3810 EUDAMEDST5311 EUDAMEDSGEA3813 EUDAMED
Identifiers
- Primary DI / UDI-DI
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- Basic UDI-DI
- B-08800041366453 EUDAMEDB-08800041366798 EUDAMEDB-08800041366736 EUDAMEDB-08800041360413 EUDAMEDB-08800041360543 EUDAMEDB-08800041366675 EUDAMEDB-08800041360642 EUDAMEDB-08800041361007 EUDAMEDB-08800041366491 EUDAMEDB-08800041360345 EUDAMEDB-08800041360376 EUDAMEDB-08800041361182 EUDAMEDB-08800041360871 EUDAMEDB-08800041361380 EUDAMEDB-08800041360574 EUDAMEDB-08800041366774 EUDAMEDB-08800041361113 EUDAMEDB-08800041360734 EUDAMEDB-08800041360895 EUDAMEDB-08800041360758 EUDAMEDB-08800041366712 EUDAMEDB-08800041361236 EUDAMEDB-08800041361052 EUDAMEDB-08800041360451 EUDAMEDB-08800041361151 EUDAMEDB-08800041366682 EUDAMEDB-08800041366699 EUDAMEDB-08800041361212 EUDAMEDB-08800041360840 EUDAMEDB-08800041360987 EUDAMEDB-08800041361243 EUDAMEDB-08800041360680 EUDAMEDB-08800041361090 EUDAMEDB-08800041360352 EUDAMEDB-08800041366446 EUDAMEDB-08800041361199 EUDAMEDB-08800041361311 EUDAMEDB-08800041360666 EUDAMEDB-08800041360338 EUDAMEDB-08800041360406 EUDAMEDB-08800041360833 EUDAMEDB-08800041360420 EUDAMEDB-08800041361328 EUDAMEDB-08800041360741 EUDAMEDB-08800041361281 EUDAMEDB-08800041366385 EUDAMEDB-08800041360154 EUDAMEDB-08800041366651 EUDAMEDB-08800041360567 EUDAMEDB-08800041360505 EUDAMEDB-08800041360178 EUDAMEDB-08800041366460 EUDAMEDB-08800041360437 EUDAMEDB-08800041366408 EUDAMEDB-08800041366392 EUDAMEDB-08800041366378 EUDAMEDB-08800041361397 EUDAMEDB-08800041360994 EUDAMEDB-08800041360802 EUDAMEDB-08800041361373 EUDAMEDB-08800041366484 EUDAMEDB-08800041366347 EUDAMEDB-08800041360789 EUDAMEDB-08800041360581 EUDAMEDB-08800041366477 EUDAMEDB-08800041360512 EUDAMEDB-08800041360468 EUDAMEDB-08800041366705 EUDAMEDB-08800041360482 EUDAMEDB-08800041360130 EUDAMEDB-08800041360321 EUDAMEDB-08800041366330 EUDAMEDB-08800041360901 EUDAMEDB-08800041360949 EUDAMEDB-08800041361175 EUDAMEDB-08800041366590 EUDAMEDB-08800041366729 EUDAMEDB-08800041361366 EUDAMEDB-08800041360673 EUDAMEDB-08800041360529 EUDAMEDB-08800041361168 EUDAMEDB-08800041361250 EUDAMEDB-08800041360932 EUDAMEDB-08800041360628 EUDAMEDB-08800041360925 EUDAMEDB-08800041360697 EUDAMEDB-08800041360598 EUDAMEDB-08800041360772 EUDAMEDB-08800041361069 EUDAMEDB-08800041360963 EUDAMEDB-08800041366415 EUDAMEDB-08800041360499 EUDAMEDB-08800041360536 EUDAMEDB-08800041361403 EUDAMEDB-08800041361120 EUDAMEDB-08800041366620 EUDAMEDB-08800041360703 EUDAMEDB-08800041366743 EUDAMEDB-08800041360635 EUDAMEDB-08800041366767 EUDAMED
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Surgical Drill by SEWONMEDIX Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800041366453 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (100)
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