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UFO-51 Universal Carbon Fiber AFO
EUDAMEDClass I (EU MDR)
Ref UFORT-MAGRef UFOLT-MAG
Identity
- Device Name
- UFO-51 Universal Carbon Fiber AFO EUDAMED
- Model / Reference
- UFORT-MAG EUDAMEDUFOLT-MAG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810079191925 EUDAMED00810079191918 EUDAMED
- Basic UDI-DI
- 081007919UAFO7Y 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
UFO-51 Universal 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 | 081007919UAFO7Y | 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 (2)
- EUDAMED 8d6c81ed-8628-4861-b776-e702dbeb6277 61 fields · synced Jun 20, 2026
- EUDAMED 49122546-9984-49db-8499-dc365e8fa49c 61 fields · synced May 18, 2026