HANGZHOU CLONGENE BIOTECH CO., LTD.

FDA Device Registration & Listing · Hangzhou Zhejiang, CN · Registration 3009414546

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009414546
FEI Number
3009414546
Entity Name
HANGZHOU CLONGENE BIOTECH CO., LTD.
City/State/Country
Hangzhou Zhejiang, CN
Establishment Address
No.1 Yichuang Road, Yuhang Sub-district, Yuhang District, Hangzhou Zhejiang 311121, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Hangzhou Clongene Biotech Co., Ltd. (Owner Number: 10051623)
Owner / Operator Contact Address
No.1 Yichuang Road, Yuhang Sub-district, Yuhang District, Hangzhou, CN-ZJ 311121, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K242802
PMA Number
N/A

All Registered Proprietary Names

CLUNGENE® FSH Menopause Rapid Test Strip CLUNGENE® FSH Menopause Rapid Test Cassette CLUNGENE® FSH Menopause Rapid Test Midstream CLUNGENE Multi-Drug Home Test Easy Cup CLUNGENE Multi-Drug Test Easy Cup CLUNGENE® Multi-Drug Test Cup CLUNGENE® Multi-Drug Test Dip Card Clungene LH Ovulation Rapid Test Midstream Clungene LH Ovulation Rapid Test Strip Clungene LH Ovulation Rapid Test Cassette CLUNGENE Fentanyl Test Cassette CLUNGENE Fentanyl Home Test Cassette

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter Clinical Chemistry Class 1 862.1300 2020-07-15
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2026-03-29
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2026-03-29
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2026-03-29
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2026-03-29
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2026-03-29
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2026-03-29
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2026-03-29
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2026-03-29
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2026-03-29
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2026-03-29
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2026-03-29
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2018-11-02
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2018-11-02
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2018-11-02
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2018-11-02
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2018-11-02
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2018-11-02
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2018-11-02
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2018-11-02
NGE Test, Luteinizing Hormone (Lh), Over The Counter Clinical Chemistry Class 1 862.1485 2017-11-30
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2024-11-24

Official Correspondent

Shujian Zheng

US Agent Details

Joe Xia Business: LSI International Inc Email: jxia@lsi-consulting.org Phone: (240) 5057880

Related Public Records

Same Entity

Hangzhou Clongene Biotech 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
K252550 Guangzhou Wondfo Biotech Co., Ltd. SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx 2025-11-18
K202567 Guangzhou Wondfo Biotech Co., Ltd. Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx 2020-09-25
K260065 Guangzhou Wondfo Biotech Co., Ltd. SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx 2026-04-28
K182701 Guangzhou Wondfo Biotech Co., Ltd. Wondfo T-Cup Multi-Drug Urine Test Cup 2018-12-03
K241741 Guangzhou Wondfo Biotech Co., Ltd. SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 2024-07-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0043-2024 Universal Meditech Inc. 1
One Step Ovulation Test REF 200-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009414546. Last updated year: 2026. Please use registration number 3009414546 when referencing this establishment in official correspondence.
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