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GFX Saliva Collector supplied in multiples of a capped tube filled with 2ml sta…

EUDAMED

Class A (EU MDR)

Ref GFX-02/BulkModel GeneFix DNA/RNA Collector, Non-SterileRef GFX-01Bulk

by Cell Projects Ltd

Identity

Trade Name
GFX Saliva Collector supplied in multiples of a capped tube filled with 2ml stabilization buffer and funnel. EUDAMED
GFX saliva collector supplied in multiples of a capped tube filled with 1ml stabilization buffer and funnel EUDAMED
Device Name
GeneFix DNA/RNA Collector, Non-sterile EUDAMED
Model / Reference
GeneFix DNA/RNA Collector, Non-Sterile EUDAMED
GFX-02/Bulk EUDAMED
GFX-01Bulk EUDAMED

Identifiers

Primary DI / UDI-DI
05060544100197 EUDAMED
05060544100180 EUDAMED
Basic UDI-DI
506054410Genefix8M EUDAMED
Direct Marketing DI
05060544100197 EUDAMED
05060544100180 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 a capped tube filled with 2ml sta… by Cell Projects Ltd — Class A — IVDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Cell Projects Ltd
EUDAMED SRN
GB-MF-000002266
Authorised Representative
Advena Limited MT-AR-000000234

Sources (2)

  • EUDAMED 9cf17447-4238-4ed4-ac26-dcd360402dfb 61 fields · synced Oct 6, 2026
  • EUDAMED a206d4e1-a610-4dfc-b351-63ff0b842b08 61 fields · synced May 18, 2026