Nucleic Acid Extraction Kit（Magnetic Beads Method）
by Biobase Biodustry(Shandong) Co., Ltd. 23 variants
Ref 96 tests/ box（126003）
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69368953NAEK131XS 06936895301585 | Date29 May 2026 | 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- Withdrawn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/IVDR Active
Specification
- Device Name
- Nucleic Acid Extraction Kit (Magnetic Beads Method)
- Model / Reference
- 96 tests/ box（126003）
- Primary DI / UDI-DI
- 06936895301585
- Basic UDI-DI
- 69368953NAEK131XS
- EMDN Code
- W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000025015
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
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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