Ardo Medical AG
UNTERAEGERI Zug, CH
ARDO MEDICAL AG appears in FDA device records in UNTERAEGERI Zug, CH. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Ardo Medical AG between 2001 and 2023. The busiest year on record is 2001, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K230590 | ARDO Bellis | HGX | Substantially Equivalent | |
| K212773 | ARDO Alyssa | HGX | Substantially Equivalent | |
| K172067 | One Mum Pumpset | HGX | Substantially Equivalent | |
| K150721 | ARDO Calypso Pro Powered Breast Pump | HGX | Substantially Equivalent | |
| K141742 | ARDO CARUM AND CALYPSO POWERED BREAST PUMPS | HGX | Substantially Equivalent | |
| K011601 | ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX | BTA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003509351 | 3003509351 | ARDO MEDICAL AG | Gewerbestrasse 19, UNTERAEGERI Zug 6314 CH | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain