510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Hangzhou Qiantang Longyue Biotechnology Co.,Ltd

Hangzhou Zhejiang, CN

Hangzhou Qiantang Longyue Biotechnology Co.,Ltd appears in FDA device records in Hangzhou Zhejiang, CN. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 6 510(k) clearances for Hangzhou Qiantang Longyue Biotechnology Co.,Ltd between 2023 and 2026. The busiest year on record is 2024, with 3. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Hangzhou Qiantang Longyue Biotechnology Co.,Ltd, by decision year
YearClearances
20231
20243
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260933Safety 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)FMISubstantially Equivalent
K260301Vial AdapterLHISubstantially Equivalent
K233287Vent Vial AdapterLHISubstantially Equivalent
K233277Filter Needle for Single UseFPBSubstantially Equivalent
K233284Vial Adapter with FilterLHISubstantially Equivalent
K222718Vial AdapterLHISubstantially Equivalent

Registered establishments

FDA registered establishments for Hangzhou Qiantang Longyue Biotechnology Co.,Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30225552903022555290Hangzhou Qiantang Longyue Biotechnology Co.,LtdRoom 104,201,301,302, Building 12, Block 1, No. 619 Wangmei Road, Linping Subdistrict, Linping District, Hangzhou Zhejiang 310000 CN2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain