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TRIAMED, CERVITEX, Soft cervical orthosis
EUDAMEDClass I (EU MDR)
Ref SRT104M4H6NModel SRT 100
Identity
- Trade Name
- TRIAMED, CERVITEX, Soft cervical orthosis EUDAMED
- Device Name
- Spinal orthoses EUDAMED
- Model / Reference
- SRT 100 EUDAMEDSRT104M4H6N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944760050279 EUDAMED
- Basic UDI-DI
- 594476005ORTCOLOANAVERTLV EUDAMED
- EMDN Code
- Y060312 CERVICAL 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, CERVITEX, Soft cervical 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 9bded5c7-ea47-401c-8ec4-70fc5b242027 61 fields · synced Jun 18, 2026