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Spectrum
EUDAMEDClass I (EU MDR)
Ref NC12922Model 1012Ref https://www.ncmedical.com/products/spectrum_1012.html?objectID=1012&queryID=867fa3ec90d2731568012a886f2e56ddRef NC12981Ref NC12979-1
Identity
- Trade Name
- Spectrum EUDAMED
- Device Name
- Spectrum EUDAMED
- Model / Reference
- 1012 EUDAMEDNC12922 EUDAMEDhttps://www.ncmedical.com/products/spectrum_1012.html?objectID=1012&queryID=867fa3ec90d2731568012a886f2e56dd EUDAMEDNC12981 EUDAMEDNC12979-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627129220 EUDAMED00768627002301 EUDAMED00768627129817 EUDAMED00768627002509 EUDAMED
- Basic UDI-DI
- 0768627CSTACC-1012-QJ EUDAMED
- Direct Marketing DI
- 00768627129220 EUDAMED00768627002301 EUDAMED00768627129817 EUDAMED00768627002509 EUDAMED
- EMDN Code
- M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES 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
Spectrum 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-1012-QJ | 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 (4)
- EUDAMED 52c65aed-f1d8-4796-85cb-40e4eb7be305 61 fields · synced Jul 13, 2026
- EUDAMED 37ba49db-d2ae-4c55-80ee-0bca4f94bfc2 61 fields · synced May 16, 2026
- EUDAMED dd3cfb18-4e8c-44fa-8aa2-1ab7f344ab2e 61 fields · synced May 18, 2026
- EUDAMED 53d8f334-759f-430d-8150-caa111659bcf 61 fields · synced May 19, 2026