Identity
- Trade Name
- COMFORTKIT 2.0 EUDAMED
- Device Name
- COMFORTKIT 2.0 EUDAMED
- Model / Reference
- 287510014 EUDAMED287510010 EUDAMED287510013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07330945681969 EUDAMED07330945681921 EUDAMED07330945681952 EUDAMED
- Basic UDI-DI
- 733094528751DM EUDAMED
- Direct Marketing DI
- 07330945681969 EUDAMED07330945681921 EUDAMED07330945681952 EUDAMED
- EMDN Code
- Y061280 LOWER LIMB ORTHOSES - ACCESSORIES 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
Comfortkit 2.0 by Camp Scandinavia AB — 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 | 733094528751DM | Class I | Active |
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Manufacturer
- Manufacturer
- Camp Scandinavia AB
- EUDAMED SRN
- SE-MF-000021395
Sources (3)
- EUDAMED 2285ee14-6b4c-4d54-bb8f-bca0bdbcc5fc 61 fields · synced Jul 15, 2026
- EUDAMED 4573eea2-366a-42c6-97f7-0f1492ec92a8 61 fields · synced May 18, 2026
- EUDAMED 51f3341d-6bf5-494c-add8-9505588aa7dd 61 fields · synced May 18, 2026