Identity
- Trade Name
- ToeOFF Flow 2½ w/o D-ring w ComfortKIT EUDAMED
- Device Name
- TOEOFF FLOW 2½ W/O D-RING W COMFORTKIT EUDAMED
- Model / Reference
- 389612014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07330945768806 EUDAMED
- Basic UDI-DI
- 733094538961ED EUDAMED
- Direct Marketing DI
- 07330945768806 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
ToeOFF Flow 2½ w/o D-ring w ComfortKIT by Camp Scandinavia AB — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 733094538961ED | Class I | Active |
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Manufacturer
- Manufacturer
- Camp Scandinavia AB
- EUDAMED SRN
- SE-MF-000021395
Sources (1)
- EUDAMED 37e284ac-9af7-4928-844a-caa908100200 61 fields · synced Jun 19, 2026