MagNXT FFPE DNA Extraction Kit
by Genes 2Me Private Limited 7 variants
Ref G2M810007-50TModel G2M810007
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 | Number890617820G2M810007GG 08906178200544 | Date24 Jun 2025 | 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- Withdrawn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
- Model / Reference
- G2M810007, G2M810007-50T
- Primary DI / UDI-DI
- 08906178200544
- Basic UDI-DI
- 890617820G2M810007GG
- Direct Marketing DI
- 08906178200544
- EMDN Code
- W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
- Device Class
- Class A
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- IN-MF-000035953
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Genes 2Me Private Limited
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