HONGKONG CONLIGHT MEDICAL GROUP LIMITED

FDA Device Registration & Listing · Tai Kok Tsui Hong Kong, CN · Registration 3034694973

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
3034694973
FEI Number
3034694973
Entity Name
HONGKONG CONLIGHT MEDICAL GROUP LIMITED
City/State/Country
Tai Kok Tsui Hong Kong, CN
Establishment Address
Rm 509 5/F THE CLOUD 111 TUNG CHAU ST, Tai Kok Tsui Hong Kong 999077, CN
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
HongKong Conlight Medical Group Limited (Owner Number: 10092121)
Owner / Operator Contact Address
Rm 509 5/F THE CLOUD 111 TUNG CHAU ST, Tai Kok Tsui, CN-HK 999077, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K232228
PMA Number
N/A

All Registered Proprietary Names

Accurature Multi-drug Urine Test Dip Card Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup,

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2024-12-06
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2024-12-06
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2024-12-06
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2024-12-06
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2024-12-06
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2024-12-06
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2024-12-06
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2024-12-06
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2024-12-06
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2024-12-06

Official Correspondent

Danning Tang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

HongKong Conlight Medical Group Limited
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
K970265 Drial Consultants, Inc. ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST 1997-04-08
K051161 Quest Diagnostics, Inc. QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) 2005-11-22
K122904 Guangzhou Wondfo Biotech Co., Ltd. WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU; 2012-11-15
K121987 Guangzhou Wondfo Biotech Co., Ltd. WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST 2012-08-01
K111560 Guangzhou Wondfo Biotech Co., Ltd. WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST 2011-07-15

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0006-2010 Biosite Inc 2
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010 Biosite Inc 2
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0008-2010 Biosite Inc 2
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0009-2010 Biosite Inc 2
Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0010-2010 Biosite Inc 2
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034694973. Last updated year: 2026. Please use registration number 3034694973 when referencing this establishment in official correspondence.
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