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2 x GFXH saliva collectors - includes funnel
EUDAMEDClass A (EU MDR)
Ref GFXHA-01/02Model GeneFix DNA/RNA Collector, Non-Sterile
Identity
- Trade Name
- 2 x GFXH saliva collectors (includes funnel, automation tube filled with 1ml stabilization buffer, 2 swabs, automation cap & instruction manual) EUDAMED
- Device Name
- GeneFix DNA/RNA Collector, Non-sterile EUDAMED
- Model / Reference
- GeneFix DNA/RNA Collector, Non-Sterile EUDAMEDGFXHA-01/02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060544100593 EUDAMED
- Basic UDI-DI
- 506054410Genefix8M EUDAMED
- Direct Marketing DI
- 05060544100593 EUDAMED
- EMDN Code
- W05019002 SALIVA COLLECTION DEVICES EUDAMED
- Models / Variants
- includes funnel EUDAMED2 swabs 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
2 x GFXH saliva collectors - includes funnel 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 (1)
- EUDAMED f7fe21b2-5c53-4e3d-ba37-188185cfe248 61 fields · synced Jun 19, 2026