Identity
- Device Name
- F5 Spiral FlexTrim Carbon Fiber AFO EUDAMED
- Model / Reference
- FSMLT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810079192205 EUDAMED
- Basic UDI-DI
- 081007919FTF564 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
F5 Spiral FlexTrim Carbon Fiber AFO by Thrive Orthopedics — 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 | 081007919FTF564 | Class I | Active |
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Manufacturer
- Manufacturer
- Thrive Orthopedics
- EUDAMED SRN
- US-MF-000026394
- Authorised Representative
- Code of Practice AB SE-AR-000003002
Sources (1)
- EUDAMED ac5f37f5-6e96-49e0-adac-043e574d533e 61 fields · synced Jun 18, 2026