MariSurgi
by Kerecis Limited Iceland EUDAMED
Ref 50205S00D0B
EMDN P900402
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2258709TD01 | Date3 Jun 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
EU market availability
Available in 32 countries, as listed in EUDAMED:
- Austriasince 29 Jan 2026
- Belgiumsince 29 Jan 2026
- Bulgariasince 29 Jan 2026
- Croatiasince 29 Jan 2026
- Cyprussince 29 Jan 2026
- Czechiasince 29 Jan 2026
- Denmarksince 29 Jan 2026
- Estoniasince 29 Jan 2026
- Finlandsince 29 Jan 2026
- Francesince 29 Jan 2026
- Germanysince 29 Jan 2026
- Greecesince 29 Jan 2026
- Hungarysince 29 Jan 2026
- Icelandsince 29 Jan 2026
- Irelandsince 29 Jan 2026
- Italysince 29 Jan 2026
- Latviasince 29 Jan 2026
- Liechtensteinsince 29 Jan 2026
- Lithuaniasince 29 Jan 2026
- Luxembourgsince 29 Jan 2026
- Maltasince 29 Jan 2026
- Netherlandssince 29 Jan 2026
- Northern Irelandsince 29 Jan 2026
- Norwaysince 29 Jan 2026
- Polandsince 29 Jan 2026
- Portugalsince 29 Jan 2026
- Romaniasince 29 Jan 2026
- Slovakiasince 29 Jan 2026
- Sloveniasince 29 Jan 2026
- Spainsince 29 Jan 2026
- Swedensince 29 Jan 2026
- Türkiyesince 29 Jan 2026
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
- 50205S00D0B
- Primary DI / UDI-DI
- 05694310966160
- 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 Limited
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 05694310966160|569431096FISHSKINNG