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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

RapidHemo — IVDR Class A IVDR by ZOVEC diagnostics GmbH

MD Atlas
ZOVEC diagnostics GmbH

EUDAMED last updated this device on Mar 17, 2026

RapidHemo

426257539RapidHemoHNL

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: ZOVEC diagnostics GmbH
UDI-DI code: 42625753900092
Reference / catalog number: RapidHemo

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Manufacturer information

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

Market distribution

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: RapidHemo
UDI-DI code: 42625753900092
Basic UDI-DI: 426257539RapidHemoHNL
Reference / catalog number: RapidHemo
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: RapidHemo fuilly integrated 7 part diff 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)

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
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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.