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F5 Spiral FlexTrim Carbon Fiber AFO
EUDAMEDClass I (EU MDR)
Ref FSSRT-MAGRef FSXSRT-MAGRef FSMRTRef FSLLT-MAGRef FSXSRTRef FSMRT-MAGRef FSLRT-MAGRef FSXSLT-MAGRef FSLRT
Identity
- Device Name
- F5 Spiral FlexTrim Carbon Fiber AFO EUDAMED
- Model / Reference
- FSSRT-MAG EUDAMEDFSXSRT-MAG EUDAMEDFSMRT EUDAMEDFSLLT-MAG EUDAMEDFSXSRT EUDAMEDFSMRT-MAG EUDAMEDFSLRT-MAG EUDAMEDFSXSLT-MAG EUDAMEDFSLRT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810079192298 EUDAMED00810079192274 EUDAMED00810079192212 EUDAMED00810079192328 EUDAMED00810079192175 EUDAMED00810079192311 EUDAMED00810079192335 EUDAMED00810079192267 EUDAMED00810079192236 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
Category: Ankle/foot orthosis
F5 Spiral FlexTrim Carbon Fiber AFO by Thrive Orthopedics — 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 | 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 (9)
- EUDAMED a3785965-f6e3-466a-9cde-751d6af62e73 61 fields · synced Aug 4, 2026
- EUDAMED a2310479-9e4f-42db-be70-aec518b48f3d 61 fields · synced May 11, 2026
- EUDAMED f2514738-c80e-4c93-aac1-b51781397653 61 fields · synced May 16, 2026
- EUDAMED 73f38f92-8d89-41f6-842f-ce4e14a2440c 61 fields · synced May 17, 2026
- EUDAMED 2e527078-95d3-4055-87f4-62223b44c912 61 fields · synced May 17, 2026
- EUDAMED 1d1dad70-ea6b-4896-807c-a168e984a4c4 61 fields · synced May 17, 2026
- EUDAMED fd08493e-d453-4a58-9a4e-1b0f1e901123 61 fields · synced May 18, 2026
- EUDAMED e1cb5d9f-79e2-415e-aed6-ac415a4b1462 61 fields · synced May 18, 2026
- EUDAMED 25dd5b63-240e-43a8-a4b0-0efbc9cdce12 61 fields · synced May 19, 2026