FDA device listing
ColpotomizOR Tube,ColpotomizOR Tube System,McCartney Tube
FDA device listing 1108666187 · TONGLU QIANYAN MEDTECH CO.,LTD
Key facts
| Proprietary names | ColpotomizOR Tube,ColpotomizOR Tube System,McCartney Tube |
|---|---|
| Owner/operator | TONGLU QIANYAN MEDTECH CO.,LTD |
| Owner/operator number | 10051702 |
| Product codes | HEW |
| Device names | HEW - Culdoscope (And Accessories) |
| Device class | Class II |
| Classification regulations (21 CFR) | 884.1640 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | TONGLU QIANYAN MEDTECH CO.,LTD |
| Establishment registrations | 3012783431 |
| FEI numbers | 3012783431 |
| Establishment operations | Contract 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