Methylmalonic Acid & Homocysteine Reagent Set
Ref 1260 M MMAH
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-1260MMMAH6Z D-1260MMMAH6Z | Date9 Jun 2022 | 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- Withdrawn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
- 1260 M MMAH
- Primary DI / UDI-DI
- D-1260MMMAH6Z
- Basic UDI-DI
- B-1260MMMAH6Z
- EMDN Code
- W0102070204, W01021307
- Device Class
- Class IVD General
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- NL-MF-000000236
Other devices from Diagnotix B.V.
Properties
Other properties (7)
- Sterile: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No