Identity
- Trade Name
- RESODURA® matrix EUDAMED
- Device Name
- Collagen Dura Substitute Membrane EUDAMED
- Model / Reference
- DUM10125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813954023212 EUDAMED
- Basic UDI-DI
- B-00813954023212 EUDAMED
- EMDN Code
- N018099 ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - ACCESSORIES - 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
RESODURA® matrix by Collagen Matrix, 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-00813954023212 | Class III | Active |
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Manufacturer
- Manufacturer
- Collagen Matrix Inc
- EUDAMED SRN
- US-MF-000015783
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 547d693c-137c-4828-be12-002ecfb36051 61 fields · synced Sep 17, 2026