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Omega Max
EUDAMEDClass I (EU MDR)
Ref NC13300Model 1027Ref NC13301-1Ref NC13301Ref NC12797Ref NC12796Ref NC12798-1Ref NC12799Ref NC12796-1Ref NC13300-1
Identity
- Trade Name
- Omega Max EUDAMED
- Device Name
- Omega Max EUDAMED
- Model / Reference
- 1027 EUDAMEDNC13300 EUDAMEDNC13301-1 EUDAMEDNC13301 EUDAMEDNC12797 EUDAMEDNC12796 EUDAMEDNC12798-1 EUDAMEDNC12799 EUDAMEDNC12796-1 EUDAMEDNC13300-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627133005 EUDAMED00768627002592 EUDAMED00768627133012 EUDAMED00768627127974 EUDAMED00768627127967 EUDAMED10768627002179 EUDAMED00768627127998 EUDAMED10768627002162 EUDAMED10768627002582 EUDAMED
- Basic UDI-DI
- 0768627CSTACC-1027-R6 EUDAMED
- Direct Marketing DI
- 00768627133005 EUDAMED00768627002592 EUDAMED00768627133012 EUDAMED00768627127974 EUDAMED00768627127967 EUDAMED10768627002179 EUDAMED00768627127998 EUDAMED10768627002162 EUDAMED10768627002582 EUDAMED
- EMDN Code
- M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Omega Max 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-1027-R6 | 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 ef611e30-d1fb-45a7-97ca-72bbc8ae3580 61 fields · synced Jul 24, 2026
- EUDAMED 1ca59fe4-e2be-4776-bea0-69115d873e11 61 fields · synced May 17, 2026
- EUDAMED d55ff354-7f8d-4c9d-8d8a-4ccfa4a48b40 61 fields · synced May 17, 2026
- EUDAMED c140fd70-4b54-4991-b646-3103c8efe00b 61 fields · synced May 18, 2026
- EUDAMED 9148f297-de37-483a-aec8-058a7e4320e2 61 fields · synced May 18, 2026
- EUDAMED 61bbd9a5-37e8-415f-9c8b-228b83261fbf 61 fields · synced May 18, 2026
- EUDAMED 4e288499-57ab-4a86-8d52-ea9f81c04760 61 fields · synced May 18, 2026
- EUDAMED c6909201-06a8-4d88-8dd0-4b7b316ab2dd 61 fields · synced May 18, 2026
- EUDAMED 6c062614-fba4-4c01-904f-627653d85a86 61 fields · synced May 18, 2026