Data / Medical devices / China / Hangzhou Qiantang Longyue Biotechnology Co.,Ltd
Hangzhou Qiantang Longyue Biotechnology Co.,Ltd: FDA-registered device maker in Hangzhou Zhejiang, China, 6 510(k) clearances
Hangzhou Qiantang Longyue Biotechnology Co.,Ltd is registered with the FDA (registration 3022555290) in Hangzhou Zhejiang, China. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 7, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022555290
- Address
- Room 104,201,301,302, Building 12, Block 1, No. 619 Wangmei Road, Linping Subdistrict, Linping District, Hangzhou Zhejiang, China, 310000
- Owner or operator
- Hangzhou Qiantang Longyue Biotechnology Co., LTD (10084683)
- Roles
- Manufacturer
- First device listed
- March 22, 2022
- Registered through
- 2026
- Brand names listed
- Dispenser Fitting, Filter Needle for Single Use, Nasal Applicator, Nasal atomized device, Safety Sterile Hypodermic Needles, Vent Vial Adapter, Vial Adapter with Filter, Vial adapter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Ent Drug | LRD | 1 | Manufacturer | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Manufacturer | accessdata.fda.gov |
| Filter, Infusion Line | FPB | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Disposable | KDC | 1 | Manufacturer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | 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 |
|---|---|---|---|---|---|---|
| August 7, 2026 | K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) | FMI | Substantially Equivalent | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | accessdata.fda.gov |
| June 5, 2026 | K260301 | Vial Adapter | LHI | Substantially Equivalent | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | accessdata.fda.gov |
| July 26, 2024 | K233287 | Vent Vial Adapter | LHI | Substantially Equivalent | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | accessdata.fda.gov |
| May 10, 2024 | K233277 | Filter Needle for Single Use | FPB | Substantially Equivalent | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | accessdata.fda.gov |
| May 1, 2024 | K233284 | Vial Adapter with Filter | LHI | Substantially Equivalent | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | accessdata.fda.gov |
| March 10, 2023 | K222718 | Vial Adapter | LHI | Substantially Equivalent | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Dispenser, Liquid Medication
- All makers of Filter, Infusion Line
- All makers of Applicator, Ent Drug
- All makers of Set, I.V. Fluid Transfer
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- All makers of Needle, Hypodermic, Single Lumen
Updated August 7, 2026. 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.