Alvatech N
by BABGENCEL GmbH Germany EUDAMED
Ref 20AS01-AG0010750Model 20AS01 / 20AS01 / 20AS03
EMDN D99
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number426071005AS000000J8 | Date18 Sep 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- MDR00145-A Issued
Quality management system EU MDR
- Notified body
- KIWA CERMET ITALIA S.P.A. 0476
- Issued
- 12 Jun 2025
- Expires
- 3 Feb 2030
Specification
- Device Name
- Alcohol Based Disinfection Spray
- Model / Reference
- 20AS01 / 20AS01 / 20AS03, 20AS01-AG0010750
- Primary DI / UDI-DI
- 42607100501084
- Basic UDI-DI
- 426071005AS000000J8
- EMDN Code
- D99 Disinfectants, antiseptics, sterilising agents and detergents for medical devices - other
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000019691
Other devices from BABGENCEL GmbH
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 79e30351-0cdc-45a8-b8e4-2113e5293599