Microalbumin (mAlb) Test Kit (Immunofluorescence)
by Nanjing Norman Biological Technology Co., Ltd. EUDAMED
Active
Ref 22402410500020Model 25 Tests /Box
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06921893001537 | Date18 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- 25 Tests /Box, 22402410500020
- Primary DI / UDI-DI
- 06921893001537
- Basic UDI-DI
- B-06921893001537
- EMDN Code
- W0102010309 Albumin (ic) incl. ualbumin
- Device Class
- Class IVD General
- Market of Registration
- Bulgaria
Manufacturer details
- EUDAMED SRN
- CN-MF-000024233
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
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Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No