MariGraft
by Kerecis Limited Iceland EUDAMED
Ref 50202N03D0B
EMDN P900402
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number569431096FishSkinNG | Date15 Oct 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2258709CE01 Issued
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 8 Jan 2026
- Expires
- 1 Oct 2030
- 2258709TD01 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 0344
- Issued
- 3 Jun 2026
- Expires
- 1 Oct 2030
- Reason
- Change approved
Specification
- Device Name
- Kerecis Fish Skin device
- Model / Reference
- 50202N03D0B
- Primary DI / UDI-DI
- 05694310966061
- Basic UDI-DI
- 569431096FishSkinNG
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- IS-MF-000001365
Other devices from Kerecis
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 05694310966061|569431096FISHSKINNG