Nucleic Acid Extraction Kit T-1728
by Wuhan MGI Tech Co., Ltd. EUDAMED
Active
Ref 1000021043Model T-1728, T-96, OP02-32, VDR03P-32, VDR02P-96, VDR03P-96, SD01T-96, SD01T-1536, FDP-32, CDP-32, CDT-192, CDT-25, CDT-48, CDT-50, BDT-864, BDT-96, MD01T-96, WDT-96, WDT-864
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697431813E-KitH4 | Date31 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- Nucleic Acid Extraction Kit
- Model / Reference
- T-1728, T-96, OP02-32, VDR03P-32, VDR02P-96, VDR03P-96, SD01T-96, SD01T-1536, FDP-32, CDP-32, CDT-192, CDT-25, CDT-48, CDT-50, BDT-864, BDT-96, MD01T-96, WDT-96, WDT-864, 1000021043
- Primary DI / UDI-DI
- 06974318130329
- Basic UDI-DI
- 697431813E-KitH4
- Direct Marketing DI
- 06974318130329
- EMDN Code
- W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
- Device Class
- Class A
- Market of Registration
- Latvia
Manufacturer details
- EUDAMED SRN
- CN-MF-000018732
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Wuhan MGI 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