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SoftSHELL for KiddieGAIT/ROCKER Youth, hearts
EUDAMEDClass I (EU MDR)
Ref 283580014Ref 283580012
Identity
- Trade Name
- SoftSHELL for KiddieGAIT/ROCKER Youth, hearts EUDAMED
- Device Name
- SoftSHELL for KiddieGAIT/ROCKER Youth, hearts EUDAMED
- Model / Reference
- 283580014 EUDAMED283580012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07330945677481 EUDAMED07330945677467 EUDAMED
- Basic UDI-DI
- 733094528358DF EUDAMED
- Direct Marketing DI
- 07330945677481 EUDAMED07330945677467 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
SoftSHELL for KiddieGAIT/ROCKER Youth, hearts 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 | 733094528358DF | Class I | Active |
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Manufacturer
- Manufacturer
- Camp Scandinavia AB
- EUDAMED SRN
- SE-MF-000021395
Sources (2)
- EUDAMED 2c488492-c8db-45c0-8f56-4f5fab89b940 61 fields · synced Jul 9, 2026
- EUDAMED dd6a927a-7934-4bb6-8e88-b3dd6ca633be 61 fields · synced May 19, 2026