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Arthrex Flex.Reamer with Flex. Guide Pin, 8.5mm
EUDAMEDClass IIa (EU MDR)
Ref 109085arModel Cruciate Ligament Instruments
Identity
- Trade Name
- Arthrex Flex.Reamer with Flex. Guide Pin, 8.5mm EUDAMED
- Device Name
- Cruciate Ligament Instruments EUDAMED
- Model / Reference
- Cruciate Ligament Instruments EUDAMED109085ar EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10810190018702 EUDAMED
- Basic UDI-DI
- 81012846CRUCIAETLIGINSV3 EUDAMED
- Direct Marketing DI
- 10810190018702 EUDAMED
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Joint prosthesis implantation kit, single-use
Arthrex Flex.Reamer with Flex. Guide Pin, 8.5mm by T.A.G. Medical products corporation LTD. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 81012846CRUCIAETLIGINSV3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- T.A.G. Medical products corporation LTD.
- EUDAMED SRN
- IL-MF-000029151
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (1)
- EUDAMED d6747fab-b72a-47a1-a72d-67c60cea5349 61 fields · synced Jul 12, 2026