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Organization name
UDI-DI code
Reference / catalog number

Z-GEM 3 — IVDD — General IVDD by ZOVEC diagnostics GmbH

MD Atlas
ZOVEC diagnostics GmbH

EUDAMED last updated this device on Apr 9, 2026

Z-GEM 3

B-42625753903062

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: ZOVEC diagnostics GmbH
UDI-DI code: 42625753903062
Reference / catalog number: Z-GEM 3

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Manufacturer information

Organization name: ZOVEC diagnostics GmbH
SRN: DE-MF-000035393
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Feb 13, 2022	Still on market

Device identification

Trade name: Z-GEM 3
UDI-DI code: 42625753903062
Basic UDI-DI: B-42625753903062
Reference / catalog number: Z-GEM 3
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Z-GEM 3, Hematology Analyzer
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0202010201AUTOMATED 3 PART HEMATOLOGY ANALYSERS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification