SafeBreath (Box of 200)
Ref FM200Model FM50
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number506043581CDMP5P 05060435810068 | Date19 Oct 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- SafeBreath Bacterial Viral Mouthpiece (Box 50)
- Model / Reference
- FM50, FM200
- Primary DI / UDI-DI
- 05060435810068
- Basic UDI-DI
- 506043581CDMP5P
- EMDN Code
- Z1399 Non-specific consumables for diagnostic instruments - other
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- UK-MF-000049022
- Authorised representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Other devices from MD Diagnostics Limited
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