Identity
- Trade Name
- BlueROCKER 2½ w D-ring w SoftKIT EUDAMED
- Device Name
- BLUEROCKER 2½ W D-RING W SOFTKIT EUDAMED
- Model / Reference
- 389742011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07330945775583 EUDAMED
- Basic UDI-DI
- 733094538974EN EUDAMED
- Direct Marketing DI
- 07330945775583 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES 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
BlueROCKER 2½ w D-ring w SoftKIT 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 | 733094538974EN | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Camp Scandinavia AB
- EUDAMED SRN
- SE-MF-000021395
Sources (1)
- EUDAMED c4bec505-b152-4633-b686-f04cfe364555 61 fields · synced Jun 18, 2026