Identity
- Trade Name
- ADL Universal Cuff, Large EUDAMED
- Device Name
- ADL Universal Cuffs EUDAMED
- Model / Reference
- 993 EUDAMEDNC35339 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627016803 EUDAMED
- Basic UDI-DI
- 0768627REHAB-993-HC EUDAMED
- Direct Marketing DI
- 00768627016803 EUDAMED
- EMDN Code
- Y150999 ASSISTIVE EATING AND DRINKING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
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
ADL Universal Cuff, Large by North Coast Medical, Inc. — 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 | 0768627REHAB-993-HC | Class I | Active |
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Manufacturer
- Manufacturer
- North Coast Medical Inc.
- EUDAMED SRN
- US-MF-000009087
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (1)
- EUDAMED c8468120-a87e-46f2-ab65-f88204c4ba04 61 fields · synced Jun 19, 2026