MateRegen Gel
by BioRegen Biomedical (Changzhou) Co., Ltd. 3 variants
Ref 40-012-001Model 2ml, 3ml, 5ml, 6ml, 8ml, 10ml, 15ml, 20ml
MateRegen Gel (40-012-001) is a Class III device made by BioRegen Biomedical (Changzhou) Co., Ltd., registered in EUDAMED on 6 Mar 2026 (Basic UDI-DI 695218124001249) with CE/MDR certificate G70 070340 0012 valid until 13 Nov 2029, active as of 24 Oct 2026.
Active
CE MDR
Valid until
13 Nov 2029
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number695218124001249 06952181200219 | Date6 Mar 2026 | StatusActive |
Official records
- EUDAMED public site 695218124001249
Certificates
- G70 070340 0012 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 14 Nov 2024
- Expires
- 13 Nov 2029
Timeline
- Certificate issued EUDAMED G70 070340 0012
- Registered EUDAMED 695218124001249
- Certificate expires EUDAMED G70 070340 0012
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Absorbable Adhesion Barrier Gel
- Model / reference
- 2ml, 3ml, 5ml, 6ml, 8ml, 10ml, 15ml, 20ml, 40-012-001
- Primary DI / UDI-DI
- 06952181200219
- Basic UDI-DI
- 695218124001249
- EMDN code
- M0406 Dressings for the prevention of post-operative adhesions
- Device class
- Class III
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000007975
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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