FDA device listing
Breast Shell DeTach 12 mm,Breast Shell DeTach 13 mm,Breast Shell DeTach 14 mm,Breast Shell DeTach 15 mm,Breast Shell…
FDA device listing 1618332724 · Ardo medical AG
Key facts
| Proprietary names | Breast Shell DeTach 12 mm,Breast Shell DeTach 13 mm,Breast Shell DeTach 14 mm,Breast Shell DeTach 15 mm,Breast Shell DeTach 16 mm,Breast Shell DeTach 17 mm,Breast Shell DeTach 18 mm,Breast Shell DeTach 21 mm,Breast Shell DeTach 24 mm,Breast Shell Insert D22,Breast Shell Insert D28,Hospital Kit DeTach 21 mm,Hospital Kit DeTach 24 mm,One Mum Pumpset D26,One Mum Pumpset D31 |
|---|---|
| Owner/operator | Ardo medical AG |
| Owner/operator number | 10040647 |
| Premarket submissions | K172067 |
| Product codes | HGX |
| Device names | HGX - Pump, Breast, Powered |
| Device class | Class II |
| Classification regulations (21 CFR) | 884.5160 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | ARDO MEDICAL AG |
| Establishment registrations | 3003509351 |
| FEI numbers | 3003509351 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database