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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Z-GEM 5R+ — IVDD — General IVDD by ZOVEC diagnostics GmbH

MD Atlas
ZOVEC diagnostics GmbH

EUDAMED last updated this device on Apr 9, 2026

Z-GEM 5R+

B-42625753903376

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: 42625753903376
Reference / catalog number: Z-GEM 5R+

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Manufacturer information

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

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 5R+
UDI-DI code: 42625753903376
Basic UDI-DI: B-42625753903376
Reference / catalog number: Z-GEM 5R+
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 5R+, Hematology Analyzer with Retic and Autoloader
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0202010101AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.