Identity
- Trade Name
- UnoDent Unowipes EUDAMED
- Device Name
- Mikrozid AF EUDAMED
- Model / Reference
- 70004106 EUDAMED70004107 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04032651986958 EUDAMED04032651986972 EUDAMED
- Basic UDI-DI
- 4032651BSC000000209Y EUDAMED
- EMDN Code
- D0799 ALCOHOLS FOR THE DISINFECTION OF MEDICAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
UnoDent Unowipes by Schülke & Mayr GmbH — Class IIa — 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 | 4032651BSC000000209Y | Class IIa | Active |
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Manufacturer
- Manufacturer
- Schülke & Mayr GmbH
- EUDAMED SRN
- DE-MF-000005701
Sources (2)
- EUDAMED 18c51f52-5097-4cc6-94e3-71b957897f5f 61 fields · synced Oct 6, 2026
- EUDAMED 2c1b87a5-1d24-49a6-8370-62cf5f9d9a08 61 fields · synced May 18, 2026