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Comfort Cool Ulnar Booster Splint R, XS
EUDAMEDClass I (EU MDR)
Ref NC68030-2Model 2890
Identity
- Trade Name
- Comfort Cool Ulnar Booster Splint R, XS EUDAMED
- Device Name
- Comfort Cool Ulnar Booster EUDAMED
- Model / Reference
- 2890 EUDAMEDNC68030-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627001106 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-2890-Q3 EUDAMED
- Direct Marketing DI
- 00768627001106 EUDAMED
- EMDN Code
- Y060619 ELBOW-WRIST-HAND ORTHOSES 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
Comfort Cool Ulnar Booster Splint R, XS 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-2890-Q3 | 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 234709b4-b37a-49a4-abcf-a969d9197026 61 fields · synced Jun 20, 2026