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TRIAMED, MALLEOFIX, Mobile ankle support with front fastening and side pads
EUDAMEDClass I (EU MDR)
Ref SRT310M3Model SRT 300Ref SRT310M1Ref SRT310M2Ref SRT310M5
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 EUDAMEDSRT310M3 EUDAMEDSRT310M1 EUDAMEDSRT310M2 EUDAMEDSRT310M5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944760054819 EUDAMED05944760054826 EUDAMED05944760054840 EUDAMED05944760054857 EUDAMED
- Basic UDI-DI
- 594476005ORTMEMBRULINFDS EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMEDY06121201 PASSIVE KNEE-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, MALLEOFIX, Mobile ankle support with front fastening and side pads 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 (4)
- EUDAMED 9d60a019-ea54-441f-b4d3-bc3b0978675c 61 fields · synced Jul 13, 2026
- EUDAMED b2e0993d-1b1d-4ae1-838b-394d80d7cea5 61 fields · synced May 17, 2026
- EUDAMED 6f499cbd-7d4d-4ad6-a207-50651c73d251 61 fields · synced May 18, 2026
- EUDAMED f1851890-0e4a-4b96-b454-860833ec0a55 61 fields · synced May 18, 2026