Identity
- Trade Name
- Lithotomy Pack II EUDAMED
- Device Name
- O.B & GYN Pack and Drapes EUDAMED
- Model / Reference
- 88521-SBBS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62811410175376 EUDAMED
- Basic UDI-DI
- 6281141EN063LA EUDAMED
- Direct Marketing DI
- 62811410175376 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
Lithotomy Pack II 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 |
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Manufacturer
- EUDAMED SRN
- SA-MF-000012228
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 9ce8b1c5-b072-419f-bd33-c3230150a9f7 61 fields · synced Oct 7, 2026