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SoftKIT Black
EUDAMEDClass I (EU MDR)
Ref 283900010Ref 283900012Ref 283900013Ref 283900011
Identity
- Trade Name
- SoftKIT Black EUDAMED
- Device Name
- SoftKIT Black EUDAMED
- Model / Reference
- 283900010 EUDAMED283900012 EUDAMED283900013 EUDAMED283900011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07330945602452 EUDAMED07330945601769 EUDAMED07330945601776 EUDAMED07330945601752 EUDAMED
- Basic UDI-DI
- 733094528390DB EUDAMED
- Direct Marketing DI
- 07330945602452 EUDAMED07330945601769 EUDAMED07330945601776 EUDAMED07330945601752 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 Black 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 | 733094528390DB | Class I | Active |
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Manufacturer
- Manufacturer
- Camp Scandinavia AB
- EUDAMED SRN
- SE-MF-000021395
Sources (4)
- EUDAMED 2af6661c-f9f3-4146-8ae7-bffd3311b8b0 61 fields · synced Jul 15, 2026
- EUDAMED 5ba700f9-cdf2-490b-80f8-494a872584cc 61 fields · synced May 17, 2026
- EUDAMED 797fedfd-81ca-4f83-9d55-1467234ec60c 61 fields · synced May 18, 2026
- EUDAMED faaa4e2d-fcaf-45f4-af3b-ca609c141b2d 61 fields · synced May 18, 2026