FDA device listing
elastic barrier strips, ostomy belt),ostomy accessories (ostomy powder, skin barrier film, adhesive remover, skin…
FDA device listing 1898527853 · Suzhou Kangyouwei Medical Technology Co., Ltd.
Key facts
| Proprietary names | elastic barrier strips, ostomy belt),ostomy accessories (ostomy powder, skin barrier film, adhesive remover, skin barrier ring, ostomy paste, |
|---|---|
| Owner/operator | Suzhou Kangyouwei Medical Technology Co., Ltd. |
| Owner/operator number | 10094574 |
| Product codes | PQE |
| Device names | PQE - Ostomy Care Kit |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5900 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | SUZHOU KANGYOUWEI MEDICAL TECHNOLOGY CO., LTD. |
| Establishment registrations | 3043106340 |
| FEI numbers | 3043106340 |
| 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