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Erba Lachema s.r.o.

Czechia CZ-MF-000024067 Last updated 17 Sep 2026

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Devices
169
Registries
EUDAMED
FDA recalls
0

Catalogue169

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About

Erba Group is a company with 50 years tradition in division of development, manufacture and sale of products for urine analysis, clinical chemistry and bacterial identification. Our mission is to provide high quality and easy accessible products for reliable, quick and comfort analysis enable right diagnosing and shorten the time of patient treatment. Thanks to combination of our own development as well as co-operative development with partners from east and west Europe, we are able to offer wide spectrum of progressive products focused on high reliable analysis together with easy and friendly using.

From the manufacturer's own website. Source

What Erba Lachema s.r.o. makes

Erba Lachema manufactures automated analyzers for urine analysis, including the Erba H560 Lyse1 and Erba H7 ret CON H, which are designed for sample processing and automated testing. It also produces the FE 125, a device for bacterial identification in clinical microbiology. These instruments are intended for laboratory use in diagnostic settings.

The company’s devices fall under EU medical device classes A and B, and they are registered in the EU’s eudamed database. Erba Lachema is based in the Czech Republic.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Erba Lachema manufacture?

Erba Lachema produces automated analyzers for urine analysis, such as the Erba H560 Lyse1 and Erba H7 ret CON H, which are used for sample processing and automated testing in laboratory settings. Additionally, it manufactures the FE 125, a device specifically designed for bacterial identification in clinical microbiology. These instruments are intended for diagnostic use in clinical laboratories.

Where is Erba Lachema based?

Erba Lachema is based in the Czech Republic. The company’s headquarters and manufacturing operations are located within this country, aligning its regulatory and operational framework with EU medical device standards.

Which regulatory registries list Erba Lachema’s devices?

Erba Lachema’s devices are registered in the eudamed database, which is the official EU registry for medical devices. This registration ensures transparency and compliance with EU medical device regulations, allowing healthcare professionals and authorities to verify the devices’ details and regulatory status.

How are Erba Lachema’s devices classified under EU regulations?

Erba Lachema’s devices fall under EU medical device classes A and B. Classification is determined by factors like the device’s intended use, risk level, and potential impact on patient safety. Class A devices pose minimal risk, while Class B devices involve a slightly higher risk, requiring additional scrutiny during design and manufacturing to ensure compliance with EU safety and performance standards.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Czechia
Address
2219/1d, Karásek, Brno, Czechia
Website
www.erba.com
Phone
+420 517 077 111
PRRC contact
Jitka Augustinová
EUDAMED SRN
CZ-MF-000024067