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Benda premifistola coesiva
EUDAMEDClass I (EU MDR)
Ref DR 10-1AModel Dispositivi Premifistola
Identity
- Trade Name
- Benda premifistola coesiva EUDAMED
- Device Name
- Bende Premifistola EUDAMED
- Model / Reference
- Dispositivi Premifistola EUDAMEDDR 10-1A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059591522509 EUDAMED
- Basic UDI-DI
- 805959152PREMN4 EUDAMED
- EMDN Code
- M030404 DIALYSIS FISTULA, BANDAGES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Benda premifistola coesiva by D.r.m. S.r.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 | 805959152PREMN4 | Class I | Active |
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Manufacturer
- Manufacturer
- D.r.m. S.r.l.
- EUDAMED SRN
- IT-MF-000027115
Sources (1)
- EUDAMED 521dedb7-6fb9-4e85-8772-90e8052bb715 61 fields · synced Jun 18, 2026