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

EUDAMED

Class A (EU MDR)

Ref RFXA-01/02Model GeneFix DNA/RNA Collector, Non-SterileRef RFXA-01/50

by Cell Projects Ltd

Identity

Trade Name
2 x RFX assisted saliva collectors, (includes funnel, tube filled with 1ml stabilization buffer, 2 swabs, cap & instruction manual) EUDAMED
50 x RFX assisted saliva collectors (includes funnel, tube filled with 1ml stabilization buffer, 2 swabs, cap & instruction manual) EUDAMED
Device Name
GeneFix DNA/RNA Collector, Non-sterile EUDAMED
Model / Reference
GeneFix DNA/RNA Collector, Non-Sterile EUDAMED
RFXA-01/02 EUDAMED
RFXA-01/50 EUDAMED

Identifiers

Primary DI / UDI-DI
05060544100494 EUDAMED
05060544100517 EUDAMED
Basic UDI-DI
506054410Genefix8M EUDAMED
Direct Marketing DI
05060544100494 EUDAMED
05060544100517 EUDAMED
EMDN Code
W05019002 SALIVA COLLECTION DEVICES EUDAMED
Models / Variants
includes funnel EUDAMED
tube filled with 1ml stabilization buffer EUDAMED
2 swabs EUDAMED
cap & 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 RFX 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 (2)

  • EUDAMED 2f1413b2-4cdb-42c5-afd4-4bd71c2244e4 61 fields · synced Oct 6, 2026
  • EUDAMED b1337a0c-bc03-430c-b960-6f6523f7e4f8 61 fields · synced May 18, 2026