Identity
- Trade Name
- Biodesign Hernia Graft EUDAMED
- Device Name
- Biodesign Hernia Graft EUDAMED
- Model / Reference
- C-SLH-8H-13X22-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-HERNIA13X22FH EUDAMED
- Basic UDI-DI
- B-HERNIA13X22FH EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Biodesign Hernia Graft by Cook Biotech Incorporated — 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-HERNIA13X22FH | Class III | Active |
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Manufacturer
- Manufacturer
- Cook Biotech Incorporated
- EUDAMED SRN
- US-MF-000001990
- Authorised Representative
- Cook Biotech Europe ApS DK-AR-000000965
Sources (1)
- EUDAMED 3ec386c6-6b0a-4823-a50d-bac0754851fc 61 fields · synced May 23, 2026