Human Lung Tissue Mycobacteria Identification Detection Kit (Nucleic Acid Mass Spectrometry)
by Xiamen Spacegen Co., Ltd. China EUDAMED
Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
EMDN W010699
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06972665704019 | Date13 Sep 2022 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Model / Reference
- Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
- Primary DI / UDI-DI
- 06972665704019
- Basic UDI-DI
- B-06972665704019
- EMDN Code
- W010699 Genetic tests - other
- Device Class
- Class IVD General
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000018018
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Xiamen Spacegen Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 299ed971-5a12-4a5f-9b3c-3fc6ebb51c5f