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Rainbow
EUDAMEDClass I (EU MDR)
Ref NC95446Model 4410Ref NC52099-5Model 4356Ref NC95442Ref NC52099-2Ref NC52099-1Ref NC95443Ref NC95447
Identity
- Trade Name
- Rainbow EUDAMEDRainbow(TM) EUDAMED
- Device Name
- Rainbow; Latex-Free Exercise Band Mini Loops EUDAMEDRainbow; FlexGel; Hand Exercisers EUDAMED
- Model / Reference
- 4410 EUDAMEDNC95446 EUDAMED4356 EUDAMEDNC52099-5 EUDAMEDNC95442 EUDAMEDNC52099-2 EUDAMEDNC52099-1 EUDAMEDNC95443 EUDAMEDNC95447 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627016056 EUDAMED00768627015042 EUDAMED00768627016254 EUDAMED00768627015011 EUDAMED00768627015004 EUDAMED00768627016278 EUDAMED00768627016063 EUDAMED
- Basic UDI-DI
- 0768627REHAB-4410-RY EUDAMED0768627REHAB-4356-SX EUDAMED
- Direct Marketing DI
- 00768627016056 EUDAMED00768627015042 EUDAMED00768627016254 EUDAMED00768627015011 EUDAMED00768627015004 EUDAMED00768627016278 EUDAMED00768627016063 EUDAMED
- EMDN Code
- Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Rainbow 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 | 0768627REHAB-4410-RY | 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 (7)
- EUDAMED f512c21a-7fc4-41a8-b378-cae994c91751 61 fields · synced Aug 2, 2026
- EUDAMED 3a9e5f3a-a37f-46f0-8a06-1b36b6b544cd 61 fields · synced May 16, 2026
- EUDAMED 74e4a4ab-281e-4491-af3f-4fab430f4bb5 61 fields · synced May 17, 2026
- EUDAMED 7a36636d-92c9-44c1-a9c8-a94e2f1cdf83 61 fields · synced May 17, 2026
- EUDAMED a235086c-3977-4b26-a189-e5716b481b37 61 fields · synced May 17, 2026
- EUDAMED 91a24be1-2eb6-4bca-bf47-57d2490c965c 61 fields · synced May 18, 2026
- EUDAMED a8e2a6a4-12b8-4ce7-a877-c596a2ab592b 61 fields · synced May 18, 2026