Identity
- Trade Name
- CareFold® Solution EUDAMED
- Device Name
- CareFold® Solution EUDAMED
- Model / Reference
- CFP-01-S-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700002302908 EUDAMED
- Basic UDI-DI
- 57000023029CareFoldFF EUDAMED
- Direct Marketing DI
- 05700002302908 EUDAMED
- EMDN Code
- V0299 NEONATOLOGY AND PAEDIATRIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Category: Assistive crawler/mobility board
CareFold® Solution by NeoCare Nordic ApS — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 57000023029CareFoldFF | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NeoCare Nordic ApS
- EUDAMED SRN
- DK-MF-000047270
Sources (1)
- EUDAMED 116d8f3f-7b22-4a3b-926d-6bc148efa6bb 61 fields · synced Aug 3, 2026