Identity
- Trade Name
- COMFIT 3,5cm x 1m EUDAMED
- Device Name
- Vendari DARIFLEX EUDAMED
- Model / Reference
- CF101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08430655534674 EUDAMED
- Basic UDI-DI
- 84306551058XER EUDAMED
- Direct Marketing DI
- 08430655534674 EUDAMED
- EMDN Code
- M0303010103 ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN TWO DIRECTIONS EUDAMED
Classification
- Device Class
- Class I 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
COMFIT 3, 5cm x 1m 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 | 84306551058XER | Class I | Active |
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Manufacturer
- Manufacturer
- Calvo Izquierdo S.L.
- EUDAMED SRN
- ES-MF-000001063
Sources (1)
- EUDAMED 62918bf3-b8d6-4355-835f-3ac6c3ae7e9a 61 fields · synced Jun 19, 2026