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ADALTIS SRL

Italy IT-MF-000028990 Last updated 21 Oct 2026

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Devices
7
Registries
EUDAMED
FDA recalls
0

Catalogue7

About

Adaltis S.r.l. is an international, IVD company headquartered in Rome, Italy. Adaltis develops, manufactures and markets in-vitro diagnostic systems and reagents to detect viral infections, diagnose immune system diseases and measure human hormone responses. Recently Adaltis developed systems and reagents for the Molecular Diagnostics / RT PCR testing (extraction and purification platform). Personal LAB - fully automated 2 plate microELISA analyser, including IFA preparation features NEXgen - fully automated 7 plate microELISA analyser, including IFA preparation features. MDXlab - Fully Integrated Nucleic Acid Extraction & Detection Universal & Compact Platform for Clinical Diagnostics - Nucleic acid extraction, PCR set-up, PCR amplification & detection EXTRAlab - advanced robotic systems for extraction & purification of nucleic acids, genomics & proteomics. Genetics AZF Microdeletions Kit - male fertility and y chromosome microdeletions

From the manufacturer's own website. Source

What ADALTIS SRL makes

Adaltis Srl manufactures in-vitro diagnostic (IVD) kits and automated analysers for detecting viral infections, including immunoassay systems like the EIAgen HCV Ab and EIAgen Detect HIV Combo Kit. Their portfolio also includes fully automated microELISA analysers (Personal LAB and NEXgen) for immune system diagnostics, as well as integrated nucleic acid extraction and detection platforms (MDXlab and EXTRAlab) for molecular diagnostics. Additional offerings include a genetics kit for male fertility testing (Genetics AZF Microdeletions Kit).

These devices fall under EU IVD Annex II List A classification and are registered in the European Union’s eudamed database. The company is headquartered in Italy.

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 Adaltis Srl manufacture?

Adaltis Srl specialises in in-vitro diagnostic (IVD) devices, including immunoassay kits like the EIAgen HCV Ab and EIAgen Detect HIV Combo Kit for detecting viral infections. Their portfolio also includes fully automated microELISA analysers (Personal LAB and NEXgen) for diagnosing immune system diseases, as well as integrated platforms for molecular diagnostics, such as MDXlab for nucleic acid extraction and detection. Additionally, they offer a genetics kit (Genetics AZF Microdeletions Kit) for male fertility testing.

Where is Adaltis Srl based, and what is its primary focus?

Adaltis Srl is headquartered in Rome, Italy. The company focuses on developing, manufacturing, and marketing in-vitro diagnostic systems and reagents. Their products target viral infection detection, immune system diagnostics, hormone response measurement, and molecular diagnostics, including automated extraction and purification platforms for clinical use.

Which regulatory registries list Adaltis Srl’s devices?

Adaltis Srl’s devices are listed in the European Union’s eudamed database, which is the official registry for in-vitro diagnostic (IVD) medical devices under EU regulations. This registry ensures transparency and traceability of IVD devices authorised for use within the EU.

How are Adaltis Srl’s devices classified under EU regulations?

Adaltis Srl’s devices fall under EU IVD Annex II List A classification. This classification applies to high-risk in-vitro diagnostic devices, such as those used for detecting infectious agents (e.g., HIV, HCV) or genetic disorders, requiring stringent regulatory oversight to ensure safety, performance, and clinical accuracy.

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

Information

Country
Italy
Address
27, Via Durini, Milano, Italy
Phone
+3907745791
PRRC contact
Roberto Steinhaus
EUDAMED SRN
IT-MF-000028990