MASTDISCS® Combi AmpC, ESβL and Carbapenemase Detection Set
Ref D72C
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-D72CFH D-D72CFH | Date7 Sep 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- Withdrawn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/IVDD Active
Specification
- Model / Reference
- D72C
- Primary DI / UDI-DI
- D-D72CFH
- Basic UDI-DI
- B-D72CFH
- EMDN Code
- W0104080502 Impregnated disks, multi-disks & tablets
- Device Class
- Class IVD General
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- GB-MF-000025209
- Authorised representative
- Mast Diagnostica GmbH DE-AR-000005299
Other devices from Mast Group, Ltd.
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No