Identity
- Trade Name
- ORTHOARTS ® Shoulder Arthroscopy Pack EUDAMED
- Device Name
- Orthopaedic Packs and Drapes EUDAMED
- Model / Reference
- 88492 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62811410686070 EUDAMED
- Basic UDI-DI
- 6281141EN062L8 EUDAMED
- Direct Marketing DI
- 62811410686070 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
ORTHOARTS ® Shoulder Arthroscopy Pack by Arabian Medical Products Manufacturing Company (Enayah) — Class I — MDR — listed in EUDAMED
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 4cde24f7-24ea-4ae9-81b7-4219d42c4d72 61 fields · synced Oct 6, 2026