Identity
- Trade Name
- ComfortKIT EUDAMED
- Device Name
- ComfortKIT EUDAMED
- Model / Reference
- 283980012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07330945653683 EUDAMED
- Basic UDI-DI
- 733094528398DT EUDAMED
- Direct Marketing DI
- 07330945653683 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 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 | 733094528398DT | Class I | Active |
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Manufacturer
- Manufacturer
- Camp Scandinavia AB
- EUDAMED SRN
- SE-MF-000021395
Sources (1)
- EUDAMED 500535c9-56a9-47e1-976b-76c70e958100 61 fields · synced Jun 18, 2026