FDA device listing
IMPROSAFE® Blood Collection Set,IMPROSAFE® Blood Collection Set with Pre-attached Holder,IMPROSAFE® Multi Sample…
FDA device listing 2020911690 · Guangzhou Improve Medical Instruments Co., Ltd.
Key facts
| Proprietary names | IMPROSAFE® Blood Collection Set,IMPROSAFE® Blood Collection Set with Pre-attached Holder,IMPROSAFE® Multi Sample Needle,IMPROSAFE® Multi Sample Needle (Flashback),IMPROVACUTER® Blood Collection Set,IMPROVACUTER® Blood Collection Set Pre-attached Holder,IMPROVACUTER® Multi Sample Needle |
|---|---|
| Owner/operator | Guangzhou Improve Medical Instruments Co., Ltd. |
| Owner/operator number | 10038705 |
| Premarket submissions | K153388 |
| Product codes | FMI |
| Device names | FMI - Needle, Hypodermic, Single Lumen |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5570 |
| Review panels | General Hospital |
| Registered establishments | GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. |
| Establishment registrations | 3008449424 |
| FEI numbers | 3008449424 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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