Nucleic Acid Extraction Kit
by Shandong Bohong Gene Technology Co., Ltd. 3 variants
Ref BH002
Nucleic Acid Extraction Kit (BH002) is a Class A device made by Shandong Bohong Gene Technology Co., Ltd., registered in EUDAMED on 25 Oct 2022 (Basic UDI-DI 6974901BH002TY), active as of 25 Oct 2026.
Active
CE IVDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number6974901BH002TY | Date25 Oct 2022 | StatusActive |
Official records
- EUDAMED public site 6974901BH002TY
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- Withdrawn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/IVDR Active
Specification
- Model / reference
- BH002
- Primary DI / UDI-DI
- 06974901970196, 06974901970660, 06974901970271, 06974901970691, 06974901970677, 06974901970325, 06974901970127, 06974901970202, 06974901972596, 06974901972589, 06974901972879, 06974901972459, 06974901972961, 06974901972800, 06974901972480, 06974901972718, 06974901972565, 06974901972770, 06974901972497, 06974901972756, 06974901972886, 06974901972992, 06974901972701, 06974901972947, 06974901972831, 06974901972541
- Basic UDI-DI
- 6974901BH002TY
- EMDN code
- W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
- Device class
- Class A
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000025971
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
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