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2 x GFX assisted saliva collectors, (includes funnel +3 more)

EUDAMED

Class A (EU MDR)

Ref GFXA-01/02Model GeneFix DNA/RNA Collector, Non-Sterile

by Cell Projects Ltd

Identity

Trade Name
2 x GFX assisted saliva collectors, ( includes funnel, tube filled with 1ml stabilization buffer, 2 swabs, cap and instruction manual) EUDAMED
Device Name
GeneFix DNA/RNA Collector, Non-sterile EUDAMED
Model / Reference
GeneFix DNA/RNA Collector, Non-Sterile EUDAMED
GFXA-01/02 EUDAMED

Identifiers

Primary DI / UDI-DI
05060544100067 EUDAMED
Basic UDI-DI
506054410Genefix8M EUDAMED
Direct Marketing DI
05060544100067 EUDAMED
EMDN Code
W05019002 SALIVA COLLECTION DEVICES EUDAMED
Models / Variants
includes funnel EUDAMED
tube filled with 1ml stabilization buffer EUDAMED
2 swabs EUDAMED
cap and 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

2 x GFX assisted saliva collectors, (includes funnel +3 more) by Cell Projects Ltd — Class A — IVDR — listed in EUDAMED — 4 models

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 653a4991-0b2e-4855-b8b9-7bd760ac58ec 61 fields · synced Oct 6, 2026