Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
Manufacturer and brand owner in Hangzhou, Zhejiang, China. 7 device types, 4 products catalogued, 6 clearances.
Hangzhou Qiantang Longyue Biotechnology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Applicator, Ent Drug, Filter, Infusion Line and 5 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2022.
7device types registered with the FDA
4products catalogued under its own name
6510(k) clearances
Registration
| Registered name | Hangzhou Qiantang Longyue Biotechnology Co.,Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3022555290 |
| FEI number | 3022555290 |
| DUNS | 601849929 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 杭州钱塘隆越生物科技有限公司 |
|---|---|
| Unified social credit code | 91330110MA2KDRQB92 |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | Room 104,201,301,302, Building 12, Block 1, No. 619 Wangmei Road, Linping Subdistrict, Linping District |
| Postal code | 310000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Applicator, Ent Drug | Class 1 | Nasal Applicator | 2023 | 1 |
| Dispenser, Liquid Medication | Class 1 | Dispenser Fitting | 2023 | 86 |
| Filter, Infusion Line | Class 2 | Filter Needle for Single Use | 2024 | 1 |
| Instrument, Surgical, Disposable | Class 1 | Vial adapter | 2022 | 45 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | Nasal atomized device | 2022 | 57 |
| Needle, Hypodermic, Single Lumen | Class 2 | Safety Sterile Hypodermic Needles | 2026 | 71 |
| Set, I.V. Fluid Transfer | Class 2 | Vent Vial Adapter, Vial Adapter with Filter, Vial adapter | 2023 | 8 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Vented Vial Adapter | LHI | 1 |
| Filter Needle for Single Use | FPB | 1 |
| Vial Adapter With Filter | LHI | 1 |
| Set, I.V. Fluid Transfer | LHI | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K260933 | 2026-08-07 | FMI | Traditional | This company |
| K260301 | 2026-06-05 | LHI | Traditional | This company |
| K233287 | 2024-07-26 | LHI | Traditional | This company |
| K233277 | 2024-05-10 | FPB | Traditional | This company |
| K233284 | 2024-05-01 | LHI | Traditional | This company |
| K222718 | 2023-03-10 | LHI | Traditional | This company |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.