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Γ-Gt

EUDAMED

Class IVD General (EU MDR)

Ref HBEL06Model HBEL06 - HBEL061

by Cypress Diagnostics

Identity

Trade Name: γ-GT EUDAMED
Device Name: γ-GT EUDAMED
Model / Reference: HBEL06 - HBEL061 EUDAMED
HBEL06 EUDAMED

Identifiers

Primary DI / UDI-DI: 05404035101544 EUDAMED
Basic UDI-DI: B-05404035101544 EUDAMED
EMDN Code: W01010116 GAMMA GLUTAMYLTRANSFERASE EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Belgium EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Category: Gamma-glutamyltransferase (GGT) IVD, reagent

Γ-Gt by Cypress Diagnostics — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Gamma-glutamyltransferase (GGT) IVD, reagent.

Gamma-GT (IFCC) — Thermo Fisher Scientific Oy · Class B
Gamma-Glutamyl Transferase Reagent — Beckman Coulter, Inc. · IVD General
γ - Glutamyltransferase (GGT) – Liquizyme (9+1) — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
Ɣ- Glutamyl transferase (GGT) (4+1) — Kalians Corporation · IVD General
Gamma-Glutamyltransferase Kit (Szasz Method/IFCC stand) — Shenzhen Mindray Bio-Medical Electronics Co.,LTD · Class B
Alinity — ABBOTT IRELAND · Class I
Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
GAMMA GT-S Kit — KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ · IVD General

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer: Cypress Diagnostics
EUDAMED SRN: BE-MF-000000033

Sources (1)

EUDAMED 5b020469-8d8c-4f5d-9595-41dc45b195b1 61 fields · synced Jul 18, 2026