Identity
- Trade Name
- Back Support platinum 3D - 2XL EUDAMED
- Device Name
- Waist support EUDAMED
- Model / Reference
- 7110-2XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05206210248064 EUDAMED
- Basic UDI-DI
- 5206210WAISTRS EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Back Support platinum 3D - 2XL by Μιχαλης Κουγιουμτζης Και Σια Ε.ε. — 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 | 5206210WAISTRS | Class I | Active |
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Manufacturer
- Manufacturer
- Μιχαλης Κουγιουμτζης Και Σια Ε.ε.
- EUDAMED SRN
- GR-MF-000015985
Sources (1)
- EUDAMED 32f0a009-1356-4e1e-9f93-e013dfe485bf 61 fields · synced Jun 18, 2026