Cell Projects Ltd
GB-MF-000002266 · United Kingdom · Maidstone
Cell Projects Ltd is registered in the European database on medical devices as a manufacturer, with 66 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 17 |
|---|
Most frequent device types declared: GeneFix DNA/RNA Collector, Non-Sterile, StoolFix.
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- 12 x GFX Saliva collectors, (includes funnel, automation tube filled w
- 12 x GFX saliva collectors (includes funnel, tube filled with 1ml stab
- 12 x RFX assisted saliva collectors (includes funnel, tube filled with
- 50 x GFX Saliva Collectors (includes funnel, tube filled with 2ml stab
- 50 x RFX saliva collectors (includes funnel, tube filled with 1ml stab
- BuccalFix stabilization buffer supplied as 500ml in HDPE bottle.
- FSS: Box of 50, Foam Saliva Swabs White reticulated polyurethane foam
- GFX Saliva Collector (includes funnel, automation tube filled with 1ml
- MS-03: 250 x 2 mini swabs per wrapper, ethylene oxide treated
- RD-01: Box of 200, 1 x shorter regular swab, Rapidri pouch and barcode
- SK-1S: 100 x 1 swab with 5ml tube and cap, individually wrapped and et
- SK-2S: 100 x 1 swab with 2ml tube and special release cap, individuall
Showing 12 of 66 declared devices.
Catalogue references include GFX-01/12, GFX-02/50, GFXH-01, GFXH-01/12, RD-01, SK-2S.
European nomenclature codes declared: W05019002, A1101, W05019001.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | CELL PROJECTS LTD (GB) · FDA 3006232406 |
| Devices in EUDAMED | 66 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 66 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Cell Projects Ltd is registered in the United States but was not found in the Canadian register.