Mouthpiece and Filter ABC
by Aktina Medical Corp 3 variants
Ref 12-210Model Mouthpiece and Filter ABC
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++B3651120008ABCVW +B365122100 | Date5 Oct 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- ABC Mouthpiece and Filter Kit (20 per box)
- Model / Reference
- Mouthpiece and Filter ABC, 12-210
- Primary DI / UDI-DI
- +B365122100
- Basic UDI-DI
- ++B3651120008ABCVW
- Direct Marketing DI
- +B365122100
- EMDN Code
- Z11010199 Linear accelerators – other
- Device Class
- Class IIa
- EU 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
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