Oncology Multi-Gene Mutations Detection Kit (High Throughput Sequencing)
by Xiamen Spacegen Co., Ltd. 2 variants
Ref Name:Lotus NL B.V. Address: Koningin Julianaplein 10,1e Verd,2595AA, The Hague,Netherlands. E-mail:[email protected]
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-06972665700240 06972665700240 | Date29 Aug 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- Withdrawn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
- Name:Lotus NL B.V. Address: Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
- Primary DI / UDI-DI
- 06972665700240
- Basic UDI-DI
- B-06972665700240
- EMDN Code
- W010699 Genetic tests - other
- Device Class
- Class IVD General
- EU 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
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