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GFX Saliva Collector (includes funnel +2 more)

EUDAMED

Class A (EU MDR)

Ref GFXH-01Model GeneFix DNA/RNA Collector, Non-Sterile

by Cell Projects Ltd

Identity

Trade Name
GFX Saliva Collector (includes funnel, automation tube filled with 1ml stabilization buffer, automation cap & instructions) EUDAMED
Device Name
GeneFix DNA/RNA Collector, Non-sterile EUDAMED
Model / Reference
GeneFix DNA/RNA Collector, Non-Sterile EUDAMED
GFXH-01 EUDAMED

Identifiers

Primary DI / UDI-DI
05060544100760 EUDAMED
Basic UDI-DI
506054410Genefix8M EUDAMED
Direct Marketing DI
05060544100760 EUDAMED
EMDN Code
W05019002 SALIVA COLLECTION DEVICES EUDAMED
Models / Variants
includes funnel EUDAMED
automation tube filled with 1ml stabilization buffer EUDAMED
automation cap & instructions 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 (includes funnel +2 more) by Cell Projects Ltd — Class A — IVDR — listed in EUDAMED — 3 models — regulatory data on deviCERTS

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 (1)

  • EUDAMED 527bf26c-1ee9-43c9-8952-6b9470175ae9 61 fields · synced Jun 18, 2026