FDA device listing
Kolplux Vaginal Speculum
FDA device listing 1584475019 · Kolplast CI Ltda
Key facts
| Proprietary names | Kolplux Vaginal Speculum |
|---|---|
| Owner/operator | Kolplast CI Ltda |
| Owner/operator number | 9005455 |
| Product codes | HIB |
| Device names | HIB - Speculum, Vaginal, Nonmetal |
| Device class | Class II |
| Classification regulations (21 CFR) | 884.4530 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | Kolplast Ci Ltda |
| Establishment registrations | 8044093 |
| FEI numbers | 3005729015 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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