Dry-type Immunofluorescence Quantitative Analyzer
by Shenzhen Microprofit Biotech Co., Ltd
Ref MF-01Model MF-T1000
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697134876001A0045UH 06971348760045 | Date27 Jul 2023 | 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- Withdrawn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/IVDR Active
Specification
- Model / Reference
- MF-T1000, MF-01
- Primary DI / UDI-DI
- 06971348760045
- Basic UDI-DI
- 697134876001A0045UH
- Direct Marketing DI
- 06971348760045
- EMDN Code
- W02010299 Immunochemistry instruments - other
- Device Class
- Class A
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000019518
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
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Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No