Identity
- Device Name
- HyaRegen Gel Pack EUDAMED
- Model / Reference
- 10ml EUDAMED40-012-010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952181201902 EUDAMED
- Basic UDI-DI
- B-06952181201902 EUDAMED
- EMDN Code
- M040204 NON-ADHERENT ABSORBENT DRESSINGS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
HyaRegen Gel Pack by BioRegen Biomedical (Changzhou) Co., 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-06952181201902 | Class III | Active |
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Manufacturer
- Manufacturer
- BioRegen Biomedical (Changzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000007975
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 91ae2668-62e9-4acd-b521-b0c095bd068b 61 fields · synced Oct 6, 2026