Non-Invasive Fetal Trisomy (NIFTY) Test Sample Collection Kit
by BGl Biotechnology (Wuhan) Co., Ltd EUDAMED
Active
Ref MFG020022Model 1 tube/kit
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697478304MFG02002242 | Date24 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Non-Invasive Fetal Trisomy (NIFTY) Test Sample Collection Kit
- Model / Reference
- 1 tube/kit, MFG020022
- Primary DI / UDI-DI
- 06974783042936
- Basic UDI-DI
- 697478304MFG02002242
- Direct Marketing DI
- 06974783042936
- EMDN Code
- W050101010201 Blood collection, tubes with additives or serum separator
- Device Class
- Class A
- Market of Registration
- Denmark
Manufacturer details
- EUDAMED SRN
- CN-MF-000050469
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from BGl Biotechnology (Wuhan) Co., Ltd
Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No