FDA device listing
Atifer Fertility Sperm Count Test for Men,get Tested sperm test,Male Sperm Count Test,Palinoia ProGenix male fertility…
FDA device listing 1429287328 · Changchun Wancheng Bio-Electron Co., Ltd.
Key facts
| Proprietary names | Atifer Fertility Sperm Count Test for Men,get Tested sperm test,Male Sperm Count Test,Palinoia ProGenix male fertility test |
|---|---|
| Owner/operator | Changchun Wancheng Bio-Electron Co., Ltd. |
| Owner/operator number | 10049606 |
| Product codes | NRF |
| Device names | NRF - Material, Quality Control, Semen Analysis |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.8625 |
| Review panels | Hematology |
| Registered establishments | CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD. |
| Establishment registrations | 3008987086 |
| FEI numbers | 3008987086 |
| 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