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12 x GFX saliva collectors (includes funnel +3 more)
EUDAMEDClass A (EU MDR)
Ref GFXA-01/12Model GeneFix DNA/RNA Collector, Non-SterileRef GFX-01/12
Identity
- Trade Name
- 12 x GFX saliva collectors (includes funnel, tube filled with 1ml stabilization buffer, 2 swabs, cap & instruction manual) EUDAMED12 x GFX saliva collectors (includes funnel, tube filled with 1ml stabilization buffer, cap & instruction manual) EUDAMED
- Device Name
- GeneFix DNA/RNA Collector, Non-sterile EUDAMED
- Model / Reference
- GeneFix DNA/RNA Collector, Non-Sterile EUDAMEDGFXA-01/12 EUDAMEDGFX-01/12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060544100074 EUDAMED05060544100012 EUDAMED
- Basic UDI-DI
- 506054410Genefix8M EUDAMED
- Direct Marketing DI
- 05060544100074 EUDAMED05060544100012 EUDAMED
- EMDN Code
- W05019002 SALIVA COLLECTION DEVICES EUDAMED
- Models / Variants
- includes funnel EUDAMED2 swabs EUDAMEDcap & instruction manual EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
12 x GFX saliva collectors (includes funnel +3 more) by Cell Projects Ltd — Class A — IVDR — listed in EUDAMED — 4 models — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 506054410Genefix8M | Class A | Active |
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Manufacturer
- Manufacturer
- Cell Projects Ltd
- EUDAMED SRN
- GB-MF-000002266
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED bcd560a9-2182-4a26-b2eb-3428704f6495 61 fields · synced Oct 6, 2026
- EUDAMED 2c959d76-8a3c-4bbd-87a4-1987019dabc0 61 fields · synced May 18, 2026