Identity
- Trade Name
- SANOFLEX 6cm x 4m EUDAMED
- Device Name
- Vendari HAFT EUDAMED
- Model / Reference
- 2106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08430655900318 EUDAMED
- Basic UDI-DI
- 8430655112XXHE EUDAMED
- EMDN Code
- M0303010201 ELASTIC FIXING BANDAGES, SELF-ADHESIVE, EXTENSIBLE IN ONE DIRECTION EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
SANOFLEX 6cm x 4m by Calvo Izquierdo S.L. — 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 | 8430655112XXHE | Class I | Active |
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Manufacturer
- Manufacturer
- Calvo Izquierdo S.L.
- EUDAMED SRN
- ES-MF-000001063
Sources (1)
- EUDAMED 08e230b7-b9f2-41cc-a2ae-30fda1239869 61 fields · synced Jun 19, 2026