Identity
- Trade Name
- MateRegen Gel EUDAMED
- Device Name
- Intrauterine Adhesion Barrier Gel EUDAMED
- Model / Reference
- II-5ml EUDAMED40-008-005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952181200271 EUDAMED
- Basic UDI-DI
- B-06952181200271 EUDAMED
- EMDN Code
- M04040501 HYDROGEL DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
MateRegen Gel by BioRegen Biomedical (Changzhou) Co., Ltd. — Class IIa — 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-06952181200271 | Class IIa | 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 a92441b2-f1b1-4d02-82e5-cb6b0bf065a1 61 fields · synced Oct 6, 2026