50 x GFX saliva collectors (includes funnel, automation tube filled with 2ml stabilization buffer, automation cap & instruction manual)
Ref GFXH-02/50, GFXH-01/50Model GeneFix DNA/RNA Collector, Non-Sterile
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 | Number506054410Genefix8M | Date21 Aug 2024 | 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- Withdrawn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
- Trade Name
- 50 x GFX saliva collectors (includes funnel, automation tube filled with 2ml stabilization buffer, automation cap & instruction manual)50 x GFX saliva collectors (includes funnel, automation tube filled with 1ml stabilization buffer, automation cap & instruction manual)
- Device Name
- GeneFix DNA/RNA Collector, Non-sterile
- Model / Reference
- GeneFix DNA/RNA Collector, Non-Sterile, GFXH-02/50, GFXH-01/50
- Primary DI / UDI-DI
- 05060544100586, 05060544100555
- Basic UDI-DI
- 506054410Genefix8M
- Direct Marketing DI
- 0506054410058605060544100555
- EMDN Code
- W05019002 Saliva collection devices
- Device Class
- Class A
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- GB-MF-000002266
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Cell Projects 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