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TRIAMED, ANKLEFIX CONFORT, Mobile ankle support with back fastening
EUDAMEDClass I (EU MDR)
Ref SRT311M3Model SRT 300Ref SRT311M5Ref SRT311M4
Identity
- Trade Name
- TRIAMED, ANKLEFIX CONFORT, Mobile ankle support with back fastening EUDAMED
- Device Name
- LOWER LIMB ORTHOSES EUDAMED
- Model / Reference
- SRT 300 EUDAMEDSRT311M3 EUDAMEDSRT311M5 EUDAMEDSRT311M4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944760054888 EUDAMED05944760054871 EUDAMED05944760054864 EUDAMED
- Basic UDI-DI
- 594476005ORTMEMBRULINFDS EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
TRIAMED, ANKLEFIX CONFORT, Mobile ankle support with back fastening by Sc Triamed Srl — 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 | 594476005ORTMEMBRULINFDS | Class I | Active |
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Manufacturer
- Manufacturer
- Sc Triamed Srl
- EUDAMED SRN
- RO-MF-000002843
Sources (3)
- EUDAMED 13ee885d-99dd-4c51-a6c3-22d790db5dc1 61 fields · synced Jul 23, 2026
- EUDAMED fd8b4ece-a796-4b46-97dc-4c2dbf83ba70 61 fields · synced May 18, 2026
- EUDAMED 9ccbff6d-02b0-4e58-a5d2-c0e98f8f1f54 61 fields · synced May 19, 2026