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DataRiver S.r.l.

Italy IT-MF-000038324 Last updated 17 Sep 2026

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Devices
2
Registries
EUDAMED
FDA recalls
0

Catalogue2

  • SurPass Ref SP200

    Class I EUDAMED Active

  • Aria Ref ARIA

    Class IIa EUDAMED Active

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

TUV Rheinland Italia SRL 1936 1 certificate

  • ITH 2378440 1 Amended

    Quality management system EU MDR

    Issued
    22 Jan 2026
    Expires
    20 Nov 2027
    Reason
    Other

Related companies

Notified bodies

What DataRiver S.r.l. makes

DataRiver S.r.l. manufactures the ARIA system, a medical device designed for data analysis and visualization in clinical environments, supporting diagnostic and monitoring workflows.

The ARIA system is classified as a Class IIa device under EU regulations and is listed in the eudamed database. The company is based 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 DataRiver S.r.l. manufacture?

DataRiver S.r.l. specializes in the ARIA system, a medical device focused on data analysis and visualization. This system is intended to support clinical workflows by enhancing diagnostic and monitoring processes, ensuring healthcare professionals can interpret and act on data more effectively.

Where is DataRiver S.r.l. based?

DataRiver S.r.l. is headquartered in Italy. The company’s location in Italy aligns with its regulatory compliance framework, particularly for devices marketed within the European Economic Area.

Which regulatory registries list DataRiver S.r.l.’s devices?

The ARIA system from DataRiver S.r.l. is listed in the eudamed database, which is the official European Union registry for medical devices. Listing in eudamed is required for transparency and traceability under EU regulations.

How are DataRiver S.r.l.’s devices classified under EU regulations?

The ARIA system is classified as a Class IIa medical device under EU regulations. This classification is determined based on factors like the device’s intended purpose, risk level, and potential impact on patient safety, with Class IIa representing a moderate-risk category requiring conformity assessment procedures.

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

Information

Country
Italy
Address
131/A, Via Divisione Acqui, Modena, Italy
Phone
+390597400905
PRRC contact
Marco Pacchioni
EUDAMED SRN
IT-MF-000038324