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TRIAMED, MALLEOFIX, Mobile ankle support with front fastening and side pads
EUDAMEDClass I (EU MDR)
Ref SRT310M4Model SRT 300
Identity
- Trade Name
- TRIAMED, MALLEOFIX, Mobile ankle support with front fastening and side pads EUDAMED
- Device Name
- LOWER LIMB ORTHOSES EUDAMED
- Model / Reference
- SRT 300 EUDAMEDSRT310M4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944760054833 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
TRIAMED, MALLEOFIX, Mobile ankle support with front fastening and side pads by Sc Triamed Srl — 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 | 594476005ORTMEMBRULINFDS | Class I | Active |
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Manufacturer
- Manufacturer
- Sc Triamed Srl
- EUDAMED SRN
- RO-MF-000002843
Sources (1)
- EUDAMED 1a5373ce-6682-4b53-8d74-de4b30d3528a 61 fields · synced Jun 17, 2026