Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022555290

FEI Number

3022555290

Entity Name

Hangzhou Qiantang Longyue Biotechnology Co.,Ltd

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Room 104,201,301,302, Building 12, Block 1, No. 619 Wangmei Road, Linping Subdistrict, Linping District, Hangzhou Zhejiang 310000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hangzhou Qiantang Longyue Biotechnology Co., LTD (Owner Number: 10084683)

Owner / Operator Contact Address

Room 302, Building 12, Building 1, No 619 Wangmei Road, Linping District, Hangzhou, CN-ZJ 31199, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233284

PMA Number

N/A

All Registered Proprietary Names

Dispenser Fitting Filter Needle for Single Use Vent Vial Adapter Nasal Applicator Vial adapter Vial adapter Vial adapter Vial Adapter with Filter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2023-12-19
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2024-05-12
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2024-07-29
LRD	Applicator, Ent Drug	Ear, Nose, Throat	Class 1	874.5220	2023-11-30
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2026-06-07
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2023-03-17
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2022-03-22
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2024-05-07

Official Correspondent

Xinlei Chen

US Agent Details

Jason Zhou Email: ShamrockIE49@hotmail.com Phone: (626) 6325067

Related Public Records

Same Entity

Hangzhou Qiantang Longyue Biotechnology Co., LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.

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3017528033	RYAN & ROSE, LLC	Bartlett, TN, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022555290. Last updated year: 2026. Please use registration number 3022555290 when referencing this establishment in official correspondence.