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Softkit 2.0 Beige
EUDAMEDClass I (EU MDR)
Ref 287490013Ref 287490011Ref 287499910Ref 287499914Ref 287509912Ref 287499912Ref 287500012Ref 287490014Ref 287509914
Identity
- Trade Name
- SOFTKIT 2.0 BEIGE EUDAMEDSOFTKIT 2.0 EUDAMED
- Device Name
- SOFTKIT 2.0 BEIGE EUDAMEDSOFTKIT 2.0 EUDAMED
- Model / Reference
- 287490013 EUDAMED287490011 EUDAMED287499910 EUDAMED287499914 EUDAMED287509912 EUDAMED287499912 EUDAMED287500012 EUDAMED287490014 EUDAMED287509914 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07330945692248 EUDAMED07330945692224 EUDAMED07330945735808 EUDAMED07330945735846 EUDAMED07330945735778 EUDAMED07330945735822 EUDAMED07330945681891 EUDAMED07330945692255 EUDAMED07330945735792 EUDAMED
- Basic UDI-DI
- 733094528749E2 EUDAMED733094528750DK EUDAMED
- Direct Marketing DI
- 07330945692248 EUDAMED07330945692224 EUDAMED07330945735808 EUDAMED07330945735846 EUDAMED07330945735778 EUDAMED07330945735822 EUDAMED07330945681891 EUDAMED07330945692255 EUDAMED07330945735792 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
Softkit 2.0 Beige 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 | 733094528749E2 | Class I | Active |
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Manufacturer
- Manufacturer
- Camp Scandinavia AB
- EUDAMED SRN
- SE-MF-000021395
Sources (9)
- EUDAMED df318847-f284-473c-af5f-20fe6d467918 61 fields · synced Sep 17, 2026
- EUDAMED a3387155-1eb9-4f02-8d2d-84a7662b62f9 61 fields · synced May 17, 2026
- EUDAMED 2bb9efa2-6351-48b7-9824-86be5f419b88 61 fields · synced May 18, 2026
- EUDAMED b522f3fd-b0d0-4cfd-ac21-2ab646e36301 61 fields · synced May 18, 2026
- EUDAMED 2c943e85-67e4-401e-936d-0926f2b92b37 61 fields · synced May 18, 2026
- EUDAMED acda54c8-c7d6-4574-8577-17b1baddfe48 61 fields · synced May 18, 2026
- EUDAMED f19dba30-4e16-428e-883b-1bec9cded1c4 61 fields · synced May 18, 2026
- EUDAMED 1ed5960b-7676-4b7a-9504-052427e1c380 61 fields · synced May 18, 2026
- EUDAMED 998d6e90-fdaa-4671-b3b3-9f53e55aac7f 61 fields · synced May 18, 2026