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Bluerocker 2.0 W/O D-Ring W Mounted Comfortkit
EUDAMEDClass I (EU MDR)
Ref 389432010
Identity
- Trade Name
- BLUEROCKER 2.0 W/O D-RING W MOUNTED COMFORTKIT EUDAMED
- Device Name
- BLUEROCKER 2.0 W/O D-RING W MOUNTED COMFORTKIT EUDAMED
- Model / Reference
- 389432010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07330945712076 EUDAMED
- Basic UDI-DI
- 733094538943EB EUDAMED
- Direct Marketing DI
- 07330945712076 EUDAMED
- EMDN Code
- Y06120602 ENERGY RETURN 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 2.0 W/O D-Ring W Mounted Comfortkit 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 | 733094538943EB | Class I | Active |
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Manufacturer
- Manufacturer
- Camp Scandinavia AB
- EUDAMED SRN
- SE-MF-000021395
Sources (1)
- EUDAMED 1f8eda4b-35c1-44fc-9304-3bb04d2a2604 61 fields · synced Jun 18, 2026