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GFX Saliva collector supplied in multiples of an automation tube filled with 2m…
EUDAMEDClass A (EU MDR)
Ref GFXH-02/BulkModel GeneFix DNA/RNA Collector, Non-Sterile
Identity
- Trade Name
- GFX Saliva collector supplied in multiples of an automation tube filled with 2ml stabilization buffer, automation cap and funnel. EUDAMED
- Device Name
- GeneFix DNA/RNA Collector, Non-sterile EUDAMED
- Model / Reference
- GeneFix DNA/RNA Collector, Non-Sterile EUDAMEDGFXH-02/Bulk EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060544100418 EUDAMED
- Basic UDI-DI
- 506054410Genefix8M EUDAMED
- Direct Marketing DI
- 05060544100418 EUDAMED
- EMDN Code
- W05019002 SALIVA COLLECTION DEVICES 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
GFX Saliva collector supplied in multiples of an automation tube filled with 2m… by Cell Projects Ltd — Class A — IVDR — listed in EUDAMED
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 a3c22637-7136-4284-af5a-80167c81b07e 61 fields · synced Jun 19, 2026