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Union Medico Aps

DenmarkFDA applicant, unverified FDA FEI 3007020251

Union Medico Aps is a medical device manufacturer, with 2 devices listed in FDA 510(k) and FDA GUDID (FDA Class II) as of 14 Nov 2026.

Devices
2
Registrations
FDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA 510(k) 1
  • FDA GUDID 1

A device listed in two registries counts in both.

Device classes
  • FDA Class II 2
Identifiers
  • FDA FEI 3007020251
  • DUNS 305456134

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI

What Union Medico Aps makes

Union Medico Aps manufactures devices designed to assist with subcutaneous self-injection, including needle guidance aids and portable injectors. These products are intended to improve ease of use for patients administering medications under the skin.

The company’s portfolio is regulated under FDA Class II devices and appears in the FDA’s 510(k) and UDI registries.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • Needle Guide Assistant 1

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Personal Injector Ref K033696

    Active Regimes: 510(k) Registry: 510(k) Class:II

Company details

FDA FEI number
3007020251
DUNS number
305456134
Address
Fruebjergvej 3, Copenhagen Hovedstaden
Phone
+4570266010

Frequently asked questions

How many devices does Union Medico Aps have in the registry?

The registry currently lists 2 devices for Union Medico Aps. Devices recorded under merged duplicate company entries are counted once.

Which registries list Union Medico Aps's devices?

Among its 2 most recently registered devices, Union Medico Aps has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Union Medico Aps's devices fall under?

Among its 2 most recently registered devices, the classes recorded for Union Medico Aps's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Union Medico Aps in the registry?

The most recently registered devices listed for Union Medico Aps include Needle Guide Assistant 1 and PERSONAL INJECTOR.

Generated automatically from registry data and not verified by a human reviewer.