HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD.

FDA Device Registration & Listing · Hangzhou Zhejiang, CN · Registration 3025349997

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
3025349997
FEI Number
3025349997
Entity Name
HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD.
City/State/Country
Hangzhou Zhejiang, CN
Establishment Address
3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, Hangzhou Zhejiang 310018, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Hangzhou Aichek Medical Technology Co., Ltd. (Owner Number: 10086006)
Owner / Operator Contact Address
3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, Hangzhou, CN-ZJ 310018, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K242498
PMA Number
N/A

All Registered Proprietary Names

HCG One Step Pregnancy Test Strip OTC HCG One Step Pregnancy Test Midstream OTC Vivoo hCG Pregnancy Test HCG One Step Pregnancy Test Strip Rx HCG One Step Pregnancy Test Midstream Rx Pocguide Multi-Drug Test Cup Pocguide Multi-Drug Test Cup OTC PocguideTM Multi-Drug Test Panel OTC PocguideTM Multi-Drug Test Panel

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2024-05-17
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2024-05-17
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2024-10-20
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2024-11-14
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2024-11-14
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2024-11-14
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2024-11-14
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2024-11-14
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2024-11-14
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2024-11-14
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2024-11-14
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2024-11-14
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2024-11-14

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

Hangzhou Aichek Medical Technology 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
K964108 Direct Access Diagnostics FACT PLUS PREGNANCY TEST 1996-11-18
K945514 Princeton BioMeditech Corp. LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG 1995-02-10
K150022 Guangzhou Wondfo Biotech Co., Ltd. Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream 2015-08-07
K043443 Guangzhou Wondfo Biotech Co., Ltd. ONE STEP HCG URINE PREGNANCY TEST 2005-04-08
K173229 Guangzhou Wondfo Biotech Co., Ltd. Preview Digital Pregnancy Test 2018-03-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0042-2024 Universal Meditech Inc. 2
One Step Pregnancy Test REF 100-01
Z-0006-05 Abbott Health Products, Inc. 2
AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025349997. Last updated year: 2026. Please use registration number 3025349997 when referencing this establishment in official correspondence.
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