Mouthpiece and Filter ABC
by Aktina Medical Corp United States EUDAMED
Ref 11-200-08-10Model Mouthpiece and Filter ABC EMDN Z11010185
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++B3651120008ABCVW | Date5 Oct 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- ABC Mouthpiece and Filter Kit (20 per box)
- Model / Reference
- Mouthpiece and Filter ABC, 11-200-08-10
- Primary DI / UDI-DI
- +B3651120008102
- Basic UDI-DI
- ++B3651120008ABCVW
- Direct Marketing DI
- +B3651120008102
- EMDN Code
- Z11010185 Linear accelerators - consumables
- Device Class
- Class IIa
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- US-MF-000005935
- Authorised representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
From the manufacturer
Manufacturer's product page: ABC Mouthpiece Filter Kit
Other devices from Aktina Medical Corp
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 eca3c4b9-2582-4406-b337-c69a97e48c42