Data / Medical devices / Denmark / Union Medico Aps
Union Medico Aps: FDA-registered device maker in Copenhagen Hovedstaden, Denmark, 1 510(k) clearance
Union Medico Aps is registered with the FDA (registration 3007020251) in Copenhagen Hovedstaden, Denmark. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 16, 2005. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007020251
- Address
- Fruebjergvej 3, Copenhagen Hovedstaden, Denmark, 2100
- Owner or operator
- Union Medico Aps (10087053)
- Roles
- Manufacturer
- First device listed
- January 6, 2023
- Registered through
- 2026
- Brand names listed
- 45 NeedleGuide Assistant, 90 NeedleGuide Assistant
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Introducer, Syringe Needle | KZH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 16, 2005 | K033696 | PERSONAL INJECTOR | KZH | Substantially Equivalent | Union Medico Aps | accessdata.fda.gov |
Compare with other makers
Updated February 16, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.