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Comfort Cool Firm D-Ring Wrist Orthosis, LXS
EUDAMEDClass I (EU MDR)
Ref NC52980Model 1158
Identity
- Trade Name
- Comfort Cool Firm D-Ring Wrist Orthosis, LXS EUDAMED
- Device Name
- Comfort Cool Firm D-Ring Wrist Orthosis EUDAMED
- Model / Reference
- 1158 EUDAMEDNC52980 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627011310 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-1158-NB EUDAMED
- Direct Marketing DI
- 00768627011310 EUDAMED
- EMDN Code
- Y060612 WRIST-HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Comfort Cool Firm D-Ring Wrist Orthosis, LXS 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 | 0768627ORTHO-1158-NB | 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 fda16641-c915-4501-a22e-fd8e373cbbe7 61 fields · synced Jun 18, 2026