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Home›China›Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

China · Hangzhou
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, South Korea, Australia — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
6listed device types
Class I 4Class II 2Class III 0
plus 9 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
2 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States9 registration records, 6 510(k), 0 PMA
Manufacturer names merged into this page: Hangzhou Qiantang Longyue Biotechnology Co.,Ltd · HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD.

Company information

Country
China
City
Hangzhou

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12023 · K222718
32024 · K233287
22026 · K260933

FDA listed device types

Instrument, Surgical, Disposable 1Nebulizer, Medicinal, Non-Ventilatory (Atomizer) 1Applicator, Ent Drug 1Dispenser, Liquid Medication 1Set, I.V. Fluid Transfer 1Filter, Infusion Line 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260933Safety 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)2026-08-07
USK260301Vial Adapter2026-06-05
USK233287Vent Vial Adapter2024-07-26

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