ZENA MAX Respiratory Panel 4 SARS-CoV-2 and Coronavirus (HKU1 +3 more)

EUDAMED

Class IVD General (EU MDR)

Ref KD146104M-100

by Advanced Molecular Diagnostics Ltd

Identity

Device Name: ZENA MAX Respiratory Panel 4 SARS-CoV-2 and Coronavirus (HKU1, NL63, OC43, 229E) EUDAMED
Model / Reference: KD146104M-100 EUDAMED

Identifiers

Primary DI / UDI-DI: 05061059980038 EUDAMED
Basic UDI-DI: B-05061059980038 EUDAMED
EMDN Code: W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED
Models / Variants: HKU1 EUDAMED
NL63 EUDAMED
OC43 EUDAMED
229E EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

ZENA MAX Respiratory Panel 4 SARS-CoV-2 and Coronavirus (HKU1 +3 more) by Advanced Molecular Diagnostics Ltd — Class IVD General — IVDD — listed in EUDAMED…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-05061059980038	Class IVD General	Active

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Manufacturer

Manufacturer: Advanced Molecular Diagnostics Ltd
EUDAMED SRN: UK-MF-000043044
Authorised Representative: Advena Limited MT-AR-000000234

Sources (1)

EUDAMED 03076343-74af-4d56-a332-942cc1ad1600 61 fields · synced Jul 8, 2026