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BlueROCKER 2½ W D-ring w mounted ComfortKIT
EUDAMEDClass I (EU MDR)
Ref 389771012
Identity
- Trade Name
- BlueROCKER 2½ W D-ring w mounted ComfortKIT EUDAMED
- Device Name
- BLUEROCKER 2½ W D-RING W MOUNTED COMFORTKIT EUDAMED
- Model / Reference
- 389771012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07330945775842 EUDAMED
- Basic UDI-DI
- 733094538977EU EUDAMED
- Direct Marketing DI
- 07330945775842 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
Category: Ankle/foot orthosis
BlueROCKER 2½ W D-ring w mounted ComfortKIT by Camp Scandinavia AB — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 | 733094538977EU | Class I | Active |
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Manufacturer
- Manufacturer
- Camp Scandinavia AB
- EUDAMED SRN
- SE-MF-000021395
Sources (1)
- EUDAMED a60bfb90-2940-444a-9b5a-73729c342531 61 fields · synced Jun 19, 2026