Identity
- Trade Name
- C-Section Pack EUDAMED
- Device Name
- O.B & GYN Pack and Drapes EUDAMED
- Model / Reference
- 88721-DH2P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62811410353644 EUDAMED
- Basic UDI-DI
- 6281141EN063LA EUDAMED
- Direct Marketing DI
- 62811410353644 EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
C-Section Pack by Arabian Medical Products Manufacturing Company (Enayah) — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6281141EN063LA | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- SA-MF-000012228
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED eadc8e34-ac06-42f2-9d10-e3c2e08c2cf0 61 fields · synced Oct 6, 2026