Identity
- Trade Name
- Sacro-Plus Back Brace EUDAMED
- Device Name
- Orthopedic Products EUDAMED
- Model / Reference
- 185 EUDAMED181 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08692195185024 EUDAMED08692195181019 EUDAMED
- Basic UDI-DI
- 8692195VO00001VP EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Sacro-Plus Back Brace by Variteks Ortopedi Sanayi A.S. — 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 | 8692195VO00001VP | Class I | Active |
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Manufacturer
- Manufacturer
- Variteks Ortopedi Sanayi A.S.
- EUDAMED SRN
- TR-MF-000026919
Sources (2)
- EUDAMED 3c6c9762-84c5-4548-904b-eecba17c1eb9 61 fields · synced Jul 27, 2026
- EUDAMED beaf0fb1-130a-4785-8c05-2c9cfd9be898 61 fields · synced May 18, 2026