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TRIAMED, OMBIFIX, Abdominal support for umbilical hernia
EUDAMEDClass I (EU MDR)
Ref SRT110M2Model SRT 100Ref SRT110M1Ref SRT110M2BLACKModel SRT100Ref SRT110M4Ref SRT110M6BLACKRef SRT110M3BLACKRef SRT110M3
Identity
- Trade Name
- TRIAMED, OMBIFIX, Abdominal support for umbilical hernia EUDAMED
- Device Name
- Spinal orthoses EUDAMED
- Model / Reference
- SRT 100 EUDAMEDSRT110M2 EUDAMEDSRT110M1 EUDAMEDSRT100 EUDAMEDSRT110M2BLACK EUDAMEDSRT110M4 EUDAMEDSRT110M6BLACK EUDAMEDSRT110M3BLACK EUDAMEDSRT110M3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944760050682 EUDAMED05944760050699 EUDAMED05944757804946 EUDAMED05944760050668 EUDAMED05944757804977 EUDAMED05944757804953 EUDAMED05944760050675 EUDAMED
- Basic UDI-DI
- 594476005ORTCOLOANAVERTLV EUDAMED59447578ORTCOLOANAVERTUG EUDAMED
- EMDN Code
- Y060406 ABDOMINAL HERNIA SUPPORTS 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: Abdominal hernia truss, reusable
TRIAMED, OMBIFIX, Abdominal support for umbilical hernia by Sc Triamed Srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Abdominal hernia truss, reusable.
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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 | 594476005ORTCOLOANAVERTLV | Class I | Active |
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Manufacturer
- Manufacturer
- Sc Triamed Srl
- EUDAMED SRN
- RO-MF-000002843
Sources (7)
- EUDAMED bd68970c-b3a0-4d45-9b43-63f9c1cb7043 61 fields · synced Jul 26, 2026
- EUDAMED bb077eae-8e92-4b6b-9467-e30286589f04 61 fields · synced May 16, 2026
- EUDAMED fbd8d252-ca16-46d2-b88e-a35e588dae4c 61 fields · synced May 17, 2026
- EUDAMED 339391a6-7889-4e88-b7a4-accd82ab6022 61 fields · synced May 17, 2026
- EUDAMED d9d247ef-c516-416d-8fa1-97d5de1c71a3 61 fields · synced May 17, 2026
- EUDAMED 9bc6c659-c041-4919-bf3d-7b31fac409e2 61 fields · synced May 18, 2026
- EUDAMED 3fab5b75-0e12-429e-9f63-a412381d5c87 61 fields · synced May 19, 2026