Identity
- Model / Reference
- 529312 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421906017380 EUDAMED
- Basic UDI-DI
- B-09421906017380 EUDAMED
- EMDN Code
- M04041001 ANIMAL-DERIVED COLLAGEN DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class III 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
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
529312 by Aroa Biosurgery Ltd. — 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-09421906017380 | Class III | Active |
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Manufacturer
- Manufacturer
- Aroa Biosurgery Ltd.
- EUDAMED SRN
- NZ-MF-000003726
- Authorised Representative
- S4M EUROPE FR-AR-000000180
Sources (1)
- EUDAMED f2a819ac-3153-4f05-af63-a4c8a15370e6 61 fields · synced Jun 18, 2026