FDA device listing
Breast Shell Insert,Calypso Double Plus,Calypso Essentials,Calypso Essentials Plus,Calypso Essentials TX,Calypso Pump…
FDA device listing 1991770876 · Ardo medical AG
Key facts
| Proprietary names | Breast Shell Insert,Calypso Double Plus,Calypso Essentials,Calypso Essentials Plus,Calypso Essentials TX,Calypso Pump Unit,Calypso-To-Go,Calypso-To-Go Pure,Carum,Carum Battery,Clinic Pumpset D26,Double Clinic Pumpset,Double Pumping Collection Kit,Double Pumpset,Easy Freeze,Hands-Free Collection Cups,Hands-Free Double Pumpset,Milk Bottles 150ml/5oz.,Single Pumpset |
|---|---|
| Owner/operator | Ardo medical AG |
| Owner/operator number | 10040647 |
| Premarket submissions | K141742 |
| 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