Osteotrans

EUDAMED

Class III (EU MDR)

Ref OLM-RRef OLRA-5Ref OA3535Ref BK1025Ref OW45Ref OAC4555Ref OH6580Ref OH4535Ref OH4545Ref OFS208ERef OLRA-6Ref OPS205H-4Ref OH4540Ref OPA6SRef OLL-RRef OA3555Ref OK0930Ref OAC4570Ref OR3340Ref OH4550Ref OR3334Ref OK1030Ref BK0920Ref OAC4550Ref OHC4550Ref OPS208H-4Ref OBXT4Ref OH6555Ref OH6545Ref OME1050Ref RK0820Ref OK0725ARef OFS210Ref OH6540Ref ORC3323Ref OK1025Ref OPA4LRef OPS216Ref BK0730Ref OA2724Ref OR4334Ref OHC4565Ref OPA4SRef OFS206-4Ref OH6535Ref ORC2220Ref OK0825Ref OW27Ref OPS204H-4Ref RK0830

by Teijin Medical Technologies Co., Ltd.

Identity

Trade Name: OSTEOTRANS EUDAMED
Device Name: OSTEOTRANS-MX EUDAMED
T-Lock OSTEOTRANS EUDAMED
OSTEOTRANS-OT EUDAMED
BioactIF OSTEOTRANS EUDAMED
Model / Reference: OLM-R EUDAMED
OLRA-5 EUDAMED
OA3535 EUDAMED
BK1025 EUDAMED
OW45 EUDAMED
OAC4555 EUDAMED
OH6580 EUDAMED
OH4535 EUDAMED
OH4545 EUDAMED
OFS208E EUDAMED
OLRA-6 EUDAMED
OPS205H-4 EUDAMED
OH4540 EUDAMED
OPA6S EUDAMED
OLL-R EUDAMED
OA3555 EUDAMED
OK0930 EUDAMED
OAC4570 EUDAMED
OR3340 EUDAMED
OH4550 EUDAMED
OR3334 EUDAMED
OK1030 EUDAMED
BK0920 EUDAMED
OAC4550 EUDAMED
OHC4550 EUDAMED
OPS208H-4 EUDAMED
OBXT4 EUDAMED
OH6555 EUDAMED
OH6545 EUDAMED
OME1050 EUDAMED
RK0820 EUDAMED
OK0725A EUDAMED
OFS210 EUDAMED
OH6540 EUDAMED
ORC3323 EUDAMED
OK1025 EUDAMED
OPA4L EUDAMED
OPS216 EUDAMED
BK0730 EUDAMED
OA2724 EUDAMED
OR4334 EUDAMED
OHC4565 EUDAMED
OPA4S EUDAMED
OFS206-4 EUDAMED
OH6535 EUDAMED
ORC2220 EUDAMED
OK0825 EUDAMED
OW27 EUDAMED
OPS204H-4 EUDAMED
RK0830 EUDAMED

Identifiers

Primary DI / UDI-DI: 04550052843279 EUDAMED
04550052844009 EUDAMED
04550052847437 EUDAMED
04550052844399 EUDAMED
04550052847222 EUDAMED
04550052847802 EUDAMED
04550052847130 EUDAMED
04550052847086 EUDAMED
04550052847109 EUDAMED
04550052843439 EUDAMED
04550052844016 EUDAMED
04550052843750 EUDAMED
04550052847093 EUDAMED
04550052843323 EUDAMED
04550052843378 EUDAMED
04550052847512 EUDAMED
04550052847994 EUDAMED
04550052847833 EUDAMED
04550052844146 EUDAMED
04550052847116 EUDAMED
04550052844139 EUDAMED
04550052844382 EUDAMED
04550052844344 EUDAMED
04550052847598 EUDAMED
04550052847642 EUDAMED
04550052843866 EUDAMED
04550052843361 EUDAMED
04550052847314 EUDAMED
04550052847291 EUDAMED
04550052843316 EUDAMED
04550052844481 EUDAMED
04550052847246 EUDAMED
04550052843453 EUDAMED
04550052847284 EUDAMED
04550052844191 EUDAMED
04550052844375 EUDAMED
04550052843255 EUDAMED
04550052843231 EUDAMED
04550052847949 EUDAMED
04550052844306 EUDAMED
04550052847468 EUDAMED
04550052844160 EUDAMED
04550052847673 EUDAMED
04550052843248 EUDAMED
04550052843767 EUDAMED
04550052847277 EUDAMED
04550052844177 EUDAMED
04550052847253 EUDAMED
04550052847482 EUDAMED
04550052843743 EUDAMED
04550052844504 EUDAMED
Basic UDI-DI: B-04550052843279 EUDAMED
B-04550052844009 EUDAMED
B-04550052847437 EUDAMED
B-04550052844399 EUDAMED
B-04550052847222 EUDAMED
B-04550052847802 EUDAMED
B-04550052847130 EUDAMED
B-04550052847086 EUDAMED
B-04550052847109 EUDAMED
B-04550052843439 EUDAMED
B-04550052844016 EUDAMED
B-04550052843750 EUDAMED
B-04550052847093 EUDAMED
B-04550052843323 EUDAMED
B-04550052843378 EUDAMED
B-04550052847512 EUDAMED
B-04550052847994 EUDAMED
B-04550052847833 EUDAMED
B-04550052844146 EUDAMED
B-04550052847116 EUDAMED
B-04550052844139 EUDAMED
B-04550052844382 EUDAMED
B-04550052844344 EUDAMED
B-04550052847598 EUDAMED
B-04550052847642 EUDAMED
B-04550052843866 EUDAMED
B-04550052843361 EUDAMED
B-04550052847314 EUDAMED
B-04550052847291 EUDAMED
B-04550052843316 EUDAMED
B-04550052844481 EUDAMED
B-04550052847246 EUDAMED
B-04550052843453 EUDAMED
B-04550052847284 EUDAMED
B-04550052844191 EUDAMED
B-04550052844375 EUDAMED
B-04550052843255 EUDAMED
B-04550052843231 EUDAMED
B-04550052847949 EUDAMED
B-04550052844306 EUDAMED
B-04550052847468 EUDAMED
B-04550052844160 EUDAMED
B-04550052847673 EUDAMED
B-04550052843248 EUDAMED
B-04550052843767 EUDAMED
B-04550052847277 EUDAMED
B-04550052844177 EUDAMED
B-04550052847253 EUDAMED
B-04550052847482 EUDAMED
B-04550052843743 EUDAMED
B-04550052844504 EUDAMED
EMDN Code: P09120599 BONE FIXATION PLATES - OTHER EUDAMED
P09120102 ANCHORS, TENDON AND LIGAMENT SYNTHESIS EUDAMED
P09120699 BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER EUDAMED
P09120605 INTERFERENCE SCREWS EUDAMED
P0999 ORTHOPAEDIC PROSTHESES, OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - OTHER EUDAMED

Classification

Device Class: Class III EUDAMED
Market of Registration: Italy EUDAMED
Germany EUDAMED
Türkiye EUDAMED
Spain EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

Yes

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Orthopaedic fixation plate, non-bioabsorbable

Osteotrans by Teijin Medical Technologies Co., Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic fixation plate, non-bioabsorbable.

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PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
AXSOS — Stryker Corp. · Class II
Xpert Wrist — NEWCLIP TECHNICS · Class II
ACUMED — ACUMED LLC · Class II
Anatomska ploča medial distal tibia 6 otvora D — Narcissus doo · Class IIb
ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union No Longer Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-04550052843279	Class III	No Longer Active

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Manufacturer

Manufacturer: Teijin Medical Technologies Co., Ltd.
EUDAMED SRN: JP-MF-000032429
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (51)

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