FDA device listing
Non-vascular Guidewires
FDA device listing 1754117753 · Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.
Key facts
| Proprietary names | Non-vascular Guidewires |
|---|---|
| Owner/operator | Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. |
| Owner/operator number | 10059339 |
| Product codes | OCY |
| Device names | OCY - Endoscopic Guidewire, Gastroenterology-Urology |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | CHANGZHOU INTL. TRADE & ENTERPRISES COOPERATIVE CO., LTD. |
| Establishment registrations | 3010612620 |
| FEI numbers | 3010612620 |
| Establishment operations | Foreign Exporter, 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