Identity
- Trade Name
- PoliWipes EUDAMED
- Device Name
- BioWipes EUDAMED
- Model / Reference
- 126 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055712800631 EUDAMED
- Basic UDI-DI
- 805571280BioWipesBP EUDAMED
- EMDN Code
- D99 DISINFECTANTS, ANTISEPTICS, STERILISING AGENTS AND DETERGENTS FOR MEDICAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
PoliWipes by Biodisin 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 | 805571280BioWipesBP | Class I | Active |
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Manufacturer
- Manufacturer
- Biodisin S.r.l
- EUDAMED SRN
- IT-MF-000031661
Sources (1)
- EUDAMED a7061308-b417-4732-a434-0285a507b6c0 61 fields · synced Aug 1, 2026