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Navigait 4-Foot Foot Drop Orthosis
EUDAMEDClass I (EU MDR)
Ref 284150012Ref 284150011Ref 284100010
Identity
- Trade Name
- NAVIGAIT 4-FOOT FOOT DROP ORTHOSIS EUDAMEDNAVIGAIT FOOT DROP ORTHOSIS EUDAMED
- Device Name
- NAVIGAIT 4-FOOT FOOT DROP ORTHOSIS EUDAMEDNAVIGAIT FOOT DROP ORTHOSIS EUDAMED
- Model / Reference
- 284150012 EUDAMED284150011 EUDAMED284100010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07330945676743 EUDAMED07330945676736 EUDAMED07330945678846 EUDAMED
- Basic UDI-DI
- 733094528415D2 EUDAMED733094528410CQ EUDAMED
- Direct Marketing DI
- 07330945676743 EUDAMED07330945676736 EUDAMED07330945678846 EUDAMED
- EMDN Code
- Y061280 LOWER LIMB ORTHOSES - ACCESSORIES EUDAMEDY06120601 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
Yes
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
Navigait 4-Foot Foot Drop Orthosis 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 | 733094528415D2 | Class I | Active |
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Manufacturer
- Manufacturer
- Camp Scandinavia AB
- EUDAMED SRN
- SE-MF-000021395
Sources (3)
- EUDAMED 9d8796b8-8ab7-40d0-ad45-3173764f5507 61 fields · synced Jul 22, 2026
- EUDAMED 872c9666-72cf-440f-8133-a0e5e36999d4 61 fields · synced May 17, 2026
- EUDAMED 7dd04772-6a16-40ca-940a-85f527fd722f 61 fields · synced May 19, 2026