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Prism
EUDAMEDClass I (EU MDR)
Ref NC12958-1Model 2386Ref NC12962Ref NC12891Ref NC12954-1Ref NC12964-1Ref NC12957-1Ref NC12956Ref NC12955-1Ref NC12964
Identity
- Trade Name
- Prism EUDAMEDPrism Perforated Sample Kit EUDAMED
- Device Name
- Prism EUDAMED
- Model / Reference
- 2386 EUDAMEDNC12958-1 EUDAMEDNC12962 EUDAMEDNC12891 EUDAMEDNC12954-1 EUDAMEDNC12964-1 EUDAMEDNC12957-1 EUDAMEDNC12956 EUDAMEDNC12955-1 EUDAMEDNC12964 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10768627002469 EUDAMED00768627129626 EUDAMED10768627128916 EUDAMED00768627002400 EUDAMED10768627002483 EUDAMED10768627002452 EUDAMED00768627129565 EUDAMED10768627002414 EUDAMED00768627129640 EUDAMED
- Basic UDI-DI
- 0768627CSTACC-2386-SZ EUDAMED
- Direct Marketing DI
- 10768627002469 EUDAMED00768627129626 EUDAMED10768627128916 EUDAMED00768627002400 EUDAMED10768627002483 EUDAMED10768627002452 EUDAMED00768627129565 EUDAMED10768627002414 EUDAMED00768627129640 EUDAMED
- EMDN Code
- M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Prism 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-2386-SZ | 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 (9)
- EUDAMED f6a346c2-9888-41b6-b10b-530a42bb6dde 61 fields · synced Jul 30, 2026
- EUDAMED 4614db80-a6c2-452f-895e-d7396eaba05f 61 fields · synced May 17, 2026
- EUDAMED fc9e28d0-0245-46ec-8c06-085420e375c6 61 fields · synced May 18, 2026
- EUDAMED 6f39bf3f-0951-4fb0-a9b7-c329e894a23c 61 fields · synced May 18, 2026
- EUDAMED d6652818-4c66-48d5-955c-ae9609002bbe 61 fields · synced May 18, 2026
- EUDAMED e69f4c66-480d-40e1-940c-a83b58d49c14 61 fields · synced May 18, 2026
- EUDAMED e04ea248-81fc-439c-8840-43523875aec8 61 fields · synced May 18, 2026
- EUDAMED 4aee76f1-b48d-4f2c-9b70-1baf61fda37d 61 fields · synced May 18, 2026
- EUDAMED 9b656644-83dd-4c2c-b2cc-5c146ac30f22 61 fields · synced May 19, 2026