Data / Medical devices / France / Union Plastic Division Ape
Union Plastic Division Ape: FDA-registered device maker in Chateau -Landon Seine-et-Marne, France, 3 510(k) clearances
Union Plastic Division Ape is registered with the FDA (registration 3016566166) in Chateau -Landon Seine-et-Marne, France. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated June 21, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016566166
- Address
- Zone Industrielle Route De Souppes, Chateau -Landon Seine-et-Marne, France, 77570
- Owner or operator
- Union Plastic (10060826)
- Roles
- Manufacturer
- First device listed
- November 28, 2023
- Registered through
- 2026
- Brand names listed
- MEDIC'UP® Vial Adapter 13mm, MEDIC'UP® Vial Adapter 20mm, RAYDYLYO® Vial Adapter 13mm - 20mm
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, I.V. Fluid Transfer | LHI | 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 |
|---|---|---|---|---|---|---|
| June 21, 2022 | K220856 | Vial Adapter Ø13mm | LHI | Substantially Equivalent | Avenir Performance Européenne Medical (Apem) | accessdata.fda.gov |
| November 19, 2019 | K190816 | Vial Adapter Ø20 mm , Vial Adapter Ø13 mm | LHI | Substantially Equivalent | Avenir Performance Europeenne Medical (Apem) | accessdata.fda.gov |
| October 15, 2019 | K190149 | Vial Adapter Ø20 mm | LHI | Substantially Equivalent | Avenir Performance Europeenne Medical (Apem) | accessdata.fda.gov |
Compare with other makers
Updated June 21, 2022. 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.