Data / Medical devices / Denmark / AMS Denmark ApS
AMS Denmark ApS: FDA-registered device maker in Hundested Hovedstaden, Denmark, 5 510(k) clearances
AMS Denmark ApS is registered with the FDA (registration 3021166069) in Hundested Hovedstaden, Denmark. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 18, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3021166069
- Address
- St Karlsmindevej 40b, Hundested Hovedstaden, Denmark, 3390
- Owner or operator
- AMS Denmark ApS (10095640)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 7, 2026
- Registered through
- 2027
- Brand names listed
- ARTSMedia High Viscosity Oil, AM-HV Oil
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Media, Reproductive | MQL | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Media, Reproductive, Exempt | QKI | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| December 18, 2024 | K241132 | ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) | MQL | Substantially Equivalent | Artsmedia Denmark Aps | accessdata.fda.gov |
| December 18, 2024 | K241095 | ARTSMedia Semen Wash Medium | MQL | Substantially Equivalent | Artsmedia Denmark Aps | accessdata.fda.gov |
| February 10, 2023 | K220715 | ARTSMedia In Vitro Culture Medium (AM-IVC Medium) | MQL | Substantially Equivalent | Artsmedia Denmark Aps | accessdata.fda.gov |
| August 16, 2007 | K070135 | VITRIFREEZE MEDIUM; VITRITHAW MEDIUM | MQL | Substantially Equivalent | Fertipro NV | accessdata.fda.gov |
| March 23, 2006 | K053494 | OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE | MQL | Substantially Equivalent | Fertipro NV | accessdata.fda.gov |
Compare with other makers
Updated December 18, 2024. 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.