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Navigait 4-Foot Drop Orthosis + Xstrong Strap
EUDAMEDClass I (EU MDR)
Ref 284160010Ref 284160011Ref 284160013
Identity
- Trade Name
- NAVIGAIT 4-FOOT DROP ORTHOSIS + XSTRONG STRAP EUDAMED
- Device Name
- NAVIGAIT 4-FOOT DROP ORTHOSIS + XSTRONG STRAP EUDAMED
- Model / Reference
- 284160010 EUDAMED284160011 EUDAMED284160013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07330945732746 EUDAMED07330945732753 EUDAMED07330945732760 EUDAMED
- Basic UDI-DI
- 733094528416D4 EUDAMED
- Direct Marketing DI
- 07330945732746 EUDAMED07330945732753 EUDAMED07330945732760 EUDAMED
- EMDN Code
- Y061280 LOWER LIMB ORTHOSES - ACCESSORIES 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 Drop Orthosis + Xstrong Strap 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 | 733094528416D4 | Class I | Active |
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Manufacturer
- Manufacturer
- Camp Scandinavia AB
- EUDAMED SRN
- SE-MF-000021395
Sources (3)
- EUDAMED 69974ce5-14a4-4708-94f1-d86b86db91ac 61 fields · synced Oct 6, 2026
- EUDAMED ac75dea4-94af-4ac2-b640-12062b27f658 61 fields · synced May 17, 2026
- EUDAMED 04d38f6c-2091-4b6c-9dde-167be4e456cd 61 fields · synced May 18, 2026