Identity
- Trade Name
- Ortho Pack III (Lower Extremity) EUDAMED
- Device Name
- Orthopaedic Packs and Drapes EUDAMED
- Model / Reference
- 88431 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62811410374670 EUDAMED
- Basic UDI-DI
- 6281141EN062L8 EUDAMED
- Direct Marketing DI
- 62811410374670 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
Ortho Pack III (Lower Extremity) 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 | 6281141EN062L8 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- SA-MF-000012228
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED a5a1ff27-19df-47f5-98af-cd3fc0d6d159 61 fields · synced Oct 6, 2026