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TRIAMED, ANKLEFIX ACTIV, Mobile ankle support with plastic side splints
EUDAMEDClass I (EU MDR)
Ref SRT314RModel SRT 300Ref SRT314L
Identity
- Trade Name
- TRIAMED, ANKLEFIX ACTIV, Mobile ankle support with plastic side splints EUDAMED
- Device Name
- LOWER LIMB ORTHOSES EUDAMED
- Model / Reference
- SRT 300 EUDAMEDSRT314R EUDAMEDSRT314L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944760055014 EUDAMED05944760055021 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 ACTIV, Mobile ankle support with plastic side splints by Sc Triamed Srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 (2)
- EUDAMED febc7c08-b1fc-4bd5-b25b-08a033a0e8c9 61 fields · synced Jul 29, 2026
- EUDAMED 4ddb7d3e-d25f-43c1-9b1c-565695b37652 61 fields · synced May 18, 2026