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Arthrex DX Reinforcement Matrix, Hydrated 5cm x 5cm
EUDAMEDClass III (EU MDR)
Ref ABS-30001Model EM00040
Identity
- Trade Name
- Arthrex DX Reinforcement Matrix, Hydrated 5cm x 5cm EUDAMED
- Device Name
- Arthrex DX Reinforcement Matrix, Hydrated EUDAMED
- Model / Reference
- EM00040 EUDAMEDABS-30001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00812337020510 EUDAMED
- Basic UDI-DI
- B-00812337020510 EUDAMED
- EMDN Code
- P900299 SURGICAL MESHES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Arthrex DX Reinforcement Matrix, Hydrated 5cm x 5cm by Dsm Biomedical, Inc. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-00812337020510 | Class III | Active |
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Manufacturer
- Manufacturer
- DSM Biomedical, Inc.
- EUDAMED SRN
- US-MF-000021393
- Authorised Representative
- DSM Biomedical B.V. NL-AR-000018633
Sources (1)
- EUDAMED e2c49bdf-44bb-4d94-b4a3-b55682915d82 61 fields · synced Jul 23, 2026