Identity
- Trade Name
- SplintCushion EUDAMED
- Device Name
- SplintCushion EUDAMED
- Model / Reference
- 826 EUDAMEDNC12904-3 EUDAMEDNC12904-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627006095 EUDAMED00768627006101 EUDAMED
- Basic UDI-DI
- 0768627CSTACC-826-94 EUDAMED
- Direct Marketing DI
- 00768627006095 EUDAMED00768627006101 EUDAMED
- EMDN Code
- M03030203 FOAM PADS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
SplintCushion 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 | 0768627CSTACC-826-94 | 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 (2)
- EUDAMED f6ffc078-9d00-4dd3-b7d6-3953f4fe3dd2 61 fields · synced Jul 26, 2026
- EUDAMED c68e23be-a50b-45bf-b8c4-f34590323c20 61 fields · synced May 17, 2026