Manually Slide Processing Kit
by Tianjin Bai Lixin Bio-tech Co., Ltd. EUDAMED
Active
Ref MN-01, MG-01
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697498683MN-01SQ | Date28 May 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Manually Slide Processing Kit
- Model / Reference
- MN-01, MG-01
- Primary DI / UDI-DI
- 06974986838442, 06974986838435
- Basic UDI-DI
- 697498683MN-01SQ, 697498683MG-01R7
- Direct Marketing DI
- 0697498683844206974986838435
- EMDN Code
- W01030799,W0202059085
- Device Class
- Class A
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000040961
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
Other devices from Tianjin Bai Lixin Bio-tech Co., Ltd.
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No