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TRIAMED, LOMBA LS FIX, Lumbosacral orthosis
EUDAMEDClass I (EU MDR)
Ref SRT137M5Model SRT 100Ref SRT137M2
Identity
- Trade Name
- TRIAMED, LOMBA LS FIX, Lumbosacral orthosis EUDAMED
- Device Name
- Spinal orthoses EUDAMED
- Model / Reference
- SRT 100 EUDAMEDSRT137M5 EUDAMEDSRT137M2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944760052129 EUDAMED05944760052150 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 (2)
- EUDAMED edbdc463-c773-4502-9c68-35f2375a82fe 61 fields · synced Jul 9, 2026
- EUDAMED f2d10eb7-819a-4997-9072-e3145127a6dc 61 fields · synced May 16, 2026