Data / Medical devices / Switzerland / Ardo Medical AG
Ardo Medical AG: FDA-registered device maker in UNTERAEGERI Zug, Switzerland, 6 510(k) clearances
Ardo Medical AG is registered with the FDA (registration 3003509351) in UNTERAEGERI Zug, Switzerland. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 30, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003509351
- Address
- Gewerbestrasse 19, UNTERAEGERI Zug, Switzerland, 6314
- Owner or operator
- Ardo medical AG (10040647)
- Roles
- Manufacturer
- First device listed
- May 2, 2012
- Registered through
- 2026
- Brand names listed
- 300.22 / UP033C Master 115V with foot switch, 300.24 / UP034C Master 115V, 310.22 / UP030C Senator 115V, ARDO SUCTION PUMP MASTER, MODEL 300.XX, ARDO SUCTION PUMP SENATOR, MODEL 310.XX, Amaryll Essentials, Amaryll Start, Ardo Alyssa and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Breast, Non-Powered | HGY | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 2 | Manufacturer | accessdata.fda.gov |
| Shield, Nipple | HFS | 1 | 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 |
|---|---|---|---|---|---|---|
| March 30, 2023 | K230590 | ARDO Bellis | HGX | Substantially Equivalent | Ardo Medical AG | accessdata.fda.gov |
| April 15, 2022 | K212773 | ARDO Alyssa | HGX | Substantially Equivalent | Ardo Medical AG | accessdata.fda.gov |
| November 29, 2017 | K172067 | One Mum Pumpset | HGX | Substantially Equivalent | Ardo Medical AG | accessdata.fda.gov |
| June 17, 2015 | K150721 | ARDO Calypso Pro Powered Breast Pump | HGX | Substantially Equivalent | Ardo Medical AG | accessdata.fda.gov |
| October 17, 2014 | K141742 | ARDO CARUM AND CALYPSO POWERED BREAST PUMPS | HGX | Substantially Equivalent | Ardo Medical AG | accessdata.fda.gov |
| June 8, 2001 | K011601 | ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX | BTA | Substantially Equivalent | Ardo Medical AG | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Breast, Powered
- All makers of Shield, Nipple
- All makers of Pump, Portable, Aspiration (Manual Or Powered)
- All makers of Pump, Breast, Non-Powered
Updated March 30, 2023. 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.