Identity
- Trade Name
- Alpha SplintStraps EUDAMED
- Device Name
- Alpha SplintStraps EUDAMED
- Model / Reference
- 935 EUDAMEDNC15276 EUDAMEDNC15277 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627152761 EUDAMED00768627152778 EUDAMED
- Basic UDI-DI
- 0768627CSTACC-935-9D EUDAMED
- Direct Marketing DI
- 00768627152761 EUDAMED00768627152778 EUDAMED
- EMDN Code
- M0303010201 ELASTIC FIXING BANDAGES, SELF-ADHESIVE, EXTENSIBLE IN ONE DIRECTION 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
Alpha SplintStraps 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-935-9D | 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 3bf6fca0-1f40-4ae7-8eb9-a26157578525 61 fields · synced Jul 22, 2026
- EUDAMED da48ac81-68b7-4fc2-a6de-6fee4ebd9455 61 fields · synced May 17, 2026