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TRIAMED, LOMBA LS FIX, Lumbosacral orthosis
EUDAMEDClass I (EU MDR)
Ref SRT137M4Model SRT 100
Identity
- Trade Name
- TRIAMED, LOMBA LS FIX, Lumbosacral orthosis EUDAMED
- Device Name
- Spinal orthoses EUDAMED
- Model / Reference
- SRT 100 EUDAMEDSRT137M4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944760052136 EUDAMED
- Basic UDI-DI
- 594476005ORTCOLOANAVERTLV EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE 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, LOMBA LS FIX, Lumbosacral orthosis 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 | 594476005ORTCOLOANAVERTLV | Class I | Active |
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Manufacturer
- Manufacturer
- Sc Triamed Srl
- EUDAMED SRN
- RO-MF-000002843
Sources (1)
- EUDAMED 0ec4944f-2034-4cae-8a5a-206854fcd8e9 61 fields · synced Jun 18, 2026