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PHX-act

EUDAMED

Class A (EU MDR)

Ref PHX-act

by GBUK Group

Identity

Model / Reference
PHX-act EUDAMED

Identifiers

Primary DI / UDI-DI
05060590880456 EUDAMED
Basic UDI-DI
506059088PHAccessoriesGK EUDAMED
Direct Marketing DI
05060590880456 EUDAMED
EMDN Code
W02079009 PH METERS EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Ireland 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

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

PHX-act by GBUK Group — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
GBUK Group
EUDAMED SRN
GB-MF-000002238
Authorised Representative
Qualrep Services B.V. NL-AR-000000537

Sources (1)

  • EUDAMED 63f86e5a-8cdc-4b94-bb8c-6ba013c80c76 61 fields · synced Jun 20, 2026