EUDAMED last updated this device on Jan 13, 2026

VZV R-GENE®

357302BUDI000597UC

On the marketIVDR Class C

Applicable legislation: —
Organization name: bioMérieux SA
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 03573026602017
Reference / catalog number: 71-022

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

VZV R-GENE® is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by bioMérieux SA. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: VZV R-GENE®
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 03573026602017
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 357302BUDI000597UC
Reference / catalog number: 71-022
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: IVDR Class C
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: The VZV R‑GENE® kit, using the real‑time PCR technology after extraction of the viral DNA, enables the detection of the genome of VZV in whole blood, plasma, CSF samples and in mucocutaneous swabs.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)03573026602017

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0105040904VARICELLA ZOSTER - NA REAGENTS

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in France; available across 30 countries total.

Country	On market since	Until
FrancePrimary placement	—	Still on market
Austria	—	Still on market
Belgium	—	Still on market
Bulgaria	—	Still on market
Cyprus	—	Still on market
Czechia	—	Still on market
Germany	—	Still on market
Denmark	—	Still on market
Estonia	—	Still on market
EL	—	Still on market
Spain	—	Still on market
Finland	—	Still on market
Croatia	—	Still on market
Hungary	—	Still on market
Ireland	—	Still on market
Iceland	—	Still on market
Italy	—	Still on market
Liechtenstein	—	Still on market
Lithuania	—	Still on market
Luxembourg	—	Still on market
Latvia	—	Still on market
Malta	—	Still on market
Netherlands	—	Still on market
Norway	—	Still on market
Poland	—	Still on market
Portugal	—	Still on market
Romania	—	Still on market
Sweden	—	Still on market
Slovenia	—	Still on market
Slovakia	—	Still on market

Related searches

IVDR Class C medical devices in EUDAMED

Device identification

Trade name: VZV R-GENE®
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 03573026602017
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 357302BUDI000597UC
Reference / catalog number: 71-022
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Device details

Quantity: 1
Additional product description: The VZV R‑GENE® kit, using the real‑time PCR technology after extraction of the viral DNA, enables the detection of the genome of VZV in whole blood, plasma, CSF samples and in mucocutaneous swabs.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

40536Supplemented
Quality management system
Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
: GMED SAS (0459)Expiry: Apr 5, 2027

Market distribution

Primary placement in France; available across 30 countries total.

Country	On market since	Until
FrancePrimary placement	—	Still on market
Austria	—	Still on market
Belgium	—	Still on market
Bulgaria	—	Still on market
Cyprus	—	Still on market
Czechia	—	Still on market
Germany	—	Still on market
Denmark	—	Still on market
Estonia	—	Still on market
EL	—	Still on market
Spain	—	Still on market
Finland	—	Still on market
Croatia	—	Still on market
Hungary	—	Still on market
Ireland	—	Still on market
Iceland	—	Still on market
Italy	—	Still on market
Liechtenstein	—	Still on market
Lithuania	—	Still on market
Luxembourg	—	Still on market
Latvia	—	Still on market
Malta	—	Still on market
Netherlands	—	Still on market
Norway	—	Still on market
Poland	—	Still on market
Portugal	—	Still on market
Romania	—	Still on market
Sweden	—	Still on market
Slovenia	—	Still on market
Slovakia	—	Still on market

VZV R-GENE®

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Certificates covering this device

Related devices