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Unomedical A/S

Denmark DK-MF-000002447 Last updated 23 Oct 2026

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Devices
29
Registries
EUDAMEDFDA
FDA recalls
0

Catalogue29

EUDAMED certificates1

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

EUDAMED certificates (1)

GMED SAS 0459 1 certificate

  • 39124 Supplemented

    Quality management system EU MDR

    Issued
    4 Sep 2026
    Expires
    30 Aug 2027
    Reason
    Add device or group

Related companies

Notified bodies

What Unomedical A/S makes

Unomedical A/S manufactures the AutoSoft+™, a reusable, disposable-free infusion pump designed for intravenous therapy in hospital settings. The device is intended for administering fluids and medications at controlled rates, with features supporting patient-specific dosing and monitoring.

The AutoSoft+™ is classified as a Class IIb medical device under EU regulations and is listed in the EUDAMED database. The company is based in Denmark.

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 Unomedical A/S manufacture?

Unomedical A/S specializes in infusion pumps, specifically the AutoSoft+™. This device is designed for intravenous therapy in hospitals, allowing controlled administration of fluids and medications without the need for disposable components. It is reusable and features patient-specific dosing and monitoring capabilities.

Where is Unomedical A/S based?

Unomedical A/S is headquartered in Denmark. The company’s location in Denmark aligns with its focus on developing infusion technology for hospital environments, particularly in Europe.

Which regulatory registries list Unomedical A/S’s devices?

Unomedical A/S’s devices, including the AutoSoft+™, are listed in the EUDAMED database. This registry is the official European Union database for medical devices, ensuring transparency and traceability of products authorized under EU regulations.

How are Unomedical A/S’s devices classified under EU regulations?

The AutoSoft+™ infusion pump manufactured by Unomedical A/S is classified as a Class IIb medical device under EU regulations. This classification is based on its intended use—administering intravenous fluids and medications in hospital settings—where it poses moderate risks requiring stringent design controls and conformity assessments.

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

Information

Country
Denmark
Address
1-3, Aaholmvej , Lejre, Denmark
Website
convatec.com
Phone
+45 31648365
PRRC contact
Rikke Eiland
EUDAMED SRN
DK-MF-000002447
FDA FEI number
1000477110