Data / Medical devices / China / Shandong Lianfa Medical Plastic Products Co. Ltd.
Shandong Lianfa Medical Plastic Products Co. Ltd.: FDA-registered device maker in JINAN Shandong, China, 2 510(k) clearances
Shandong Lianfa Medical Plastic Products Co. Ltd. is registered with the FDA (registration 3003723176) in JINAN Shandong, China. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 30, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003723176
- FEI number
- 3008801456
- Address
- No.1 Shuangshan Sanjian Road, Zhangqiu, JINAN Shandong, China, 250200
- Owner or operator
- SHANDONG LIANFA MEDICAL PLASTIC PRODUCTS CO. LTD. (9050813)
- Roles
- Manufacturer
- First device listed
- December 3, 2022
- Registered through
- 2026
- Brand names listed
- Adhesive Remover, CGM Adhesive Patch, Embrace Lancing Device With Ejector, Embrace Sterile Lancet, Insulin Pump Adhesie Patch, Lancing Device, Lancing System, Lianfa Safety Lancet and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Liquid, Skin Protectant | NEC | 1 | Manufacturer | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Manufacturer | accessdata.fda.gov |
| Solvent, Adhesive Tape | KOX | 1 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 30, 2022 | K222472 | Lancing System, Sterile Lancet for Single Use, Lancing Device | QRL | Substantially Equivalent | Shandong Lianfa Medical Plastic Products Co. , Ltd. | accessdata.fda.gov |
| October 3, 2022 | K222376 | Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) | FMK | Substantially Equivalent | Shandong Lianfa Medical Plastic Products Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Tape And Bandage, Adhesive
- All makers of Bandage, Liquid, Skin Protectant
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
- All makers of Solvent, Adhesive Tape
Updated November 30, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.