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SoftKIT for KiddieGAIT /ROCKER
EUDAMEDClass I (EU MDR)
Ref 283780014Ref 283780013
Identity
- Trade Name
- SoftKIT for KiddieGAIT /ROCKER EUDAMED
- Device Name
- SoftKIT for KiddieGAIT /ROCKER EUDAMED
- Model / Reference
- 283780014 EUDAMED283780013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07330945677399 EUDAMED07330945677368 EUDAMED
- Basic UDI-DI
- 733094528378DM EUDAMED
- Direct Marketing DI
- 07330945677399 EUDAMED07330945677368 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 for KiddieGAIT /ROCKER 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 | 733094528378DM | Class I | Active |
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Manufacturer
- Manufacturer
- Camp Scandinavia AB
- EUDAMED SRN
- SE-MF-000021395
Sources (2)
- EUDAMED 44938701-3e07-49a1-ab06-cb05d7bc8c18 61 fields · synced Jul 21, 2026
- EUDAMED 4763a4ad-313f-435e-ada0-c08508f24c9d 61 fields · synced May 17, 2026