Data / Medical devices / France / Araymondlife
Araymondlife: FDA-registered device maker in Voreppe Isere, France, 1 510(k) clearance
Araymondlife is registered with the FDA (registration 3011392709) in Voreppe Isere, France. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 19, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011392709
- Address
- 365 Rue Irene Joliot-Curie Centr Alp 2, Voreppe Isere, France, 38340
- Owner or operator
- ARaymondlife (10056425)
- Roles
- Contract manufacturer, Exporter to the US
- First device listed
- September 3, 2018
- Registered through
- 2026
- Brand names listed
- STERILE DISPOSABLE GUIDE, VIAL ADAPTER FOR RAYDYLYO
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, I.V. Fluid Transfer | LHI | 2 | Exporter to the US | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| November 19, 2019 | K190816 | Vial Adapter Ø20 mm , Vial Adapter Ø13 mm | LHI | Substantially Equivalent | Avenir Performance Europeenne Medical (Apem) | accessdata.fda.gov |
Compare with other makers
Updated November 19, 2019. 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.