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Biodesign Hernia Graft

EUDAMED

Class III (EU MDR)

Ref C-SLH-8H-20X20-2Ref C-SLH-8H-13X15-2Model C-SLH-8H-13X15-2Ref C-SLH-8H-10X10-2Ref C-SLH-8H-20X30-2

by Cook Biotech Incorporated

Identity

Trade Name
Biodesign Hernia Graft EUDAMED
Device Name
Biodesign Hernia Graft EUDAMED
Model / Reference
C-SLH-8H-20X20-2 EUDAMED
C-SLH-8H-13X15-2 EUDAMED
C-SLH-8H-10X10-2 EUDAMED
C-SLH-8H-20X30-2 EUDAMED

Identifiers

Primary DI / UDI-DI
D-HERNIA20X20F3 EUDAMED
D-HERNIA13X15FL EUDAMED
D-HERNIA10X10EM EUDAMED
D-HERNIA20X30F6 EUDAMED
Basic UDI-DI
B-HERNIA20X20F3 EUDAMED
B-HERNIA13X15FL EUDAMED
B-HERNIA10X10EM EUDAMED
B-HERNIA20X30F6 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

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Manufacturer

Manufacturer
Cook Biotech Incorporated
EUDAMED SRN
US-MF-000001990
Authorised Representative
Cook Biotech Europe ApS DK-AR-000000965

Sources (4)

  • EUDAMED 1bbf900f-5f97-4d59-a22e-7d1745a0cf74 61 fields · synced Jul 26, 2026
  • EUDAMED 9783e1a6-6377-44f1-91fe-9ac48acbb7a6 61 fields · synced May 17, 2026
  • EUDAMED b6b7f864-038f-469d-8ae1-07143a91aa6f 61 fields · synced Jul 13, 2026
  • EUDAMED c39ad2e5-1a78-4695-8022-4c5eba26fa6c 61 fields · synced Jul 26, 2026