FDA device listing
Embrace Lancing Device With Ejector,Embrace Sterile Lancet,Lancing Device,Lancing System,Sterile Lancet for Single…
FDA device listing 1038304851 · SHANDONG LIANFA MEDICAL PLASTIC PRODUCTS CO. LTD.
Key facts
| Proprietary names | Embrace Lancing Device With Ejector,Embrace Sterile Lancet,Lancing Device,Lancing System,Sterile Lancet for Single Use,Twist Lancet |
|---|---|
| Owner/operator | SHANDONG LIANFA MEDICAL PLASTIC PRODUCTS CO. LTD. |
| Owner/operator number | 9050813 |
| Premarket submissions | K222472 |
| Product codes | QRK, QRL |
| Device names | QRK - Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature, QRL - Multiple Use Blood Lancet For Single Patient Use Only |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4850 |
| Review panels | General & Plastic Surgery |
| Registered establishments | SHANDONG LIANFA MEDICAL PLASTIC PRODUCTS CO. LTD. |
| Establishment registrations | 3003723176 |
| FEI numbers | 3008801456 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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