FDA device listing
RIGISTER CUPULE 20 mm,RIGISTER CUPULE 25 mm,RIGISTER CUPULE 30 mm,RIGISTER CUPULE 35 mm,SLIDING RIGISTER CUPULE 20…
FDA device listing 1529525157 · LABORATOIRE CCD
Key facts
| Proprietary names | RIGISTER CUPULE 20 mm,RIGISTER CUPULE 25 mm,RIGISTER CUPULE 30 mm,RIGISTER CUPULE 35 mm,SLIDING RIGISTER CUPULE 20 mm,SLIDING RIGISTER CUPULE 25 mm,SLIDING RIGISTER CUPULE 30 mm,SLIDING RIGISTER CUPULE 35 mm |
|---|---|
| Owner/operator | LABORATOIRE CCD |
| Owner/operator number | 10061040 |
| Premarket submissions | K894259 |
| Product codes | HIG |
| Device names | HIG - Insufflator, Hysteroscopic |
| Device class | Class II |
| Classification regulations (21 CFR) | 884.1700 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | LABORATOIRE CCD |
| Establishment registrations | 3005136445 |
| FEI numbers | 3005136445 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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