Hongkong Conlight Medical Group Limited
Registered establishment in Tai Kok Tsui, Hong Kong, China. 11 device types.
Hongkong Conlight Medical Group Limited is a specification developer holding a current FDA establishment registration. The registration covers Strip, Test Isoniazid, Enzyme Immunoassay, Opiates and 9 other device types. Its earliest product listing with the FDA dates from 2024.
Registration
| Registered name | HONGKONG CONLIGHT MEDICAL GROUP LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3034694973 |
| FEI number | 3034694973 |
| Establishment type | Specification developer, Manufacturer |
Location
| City | Tai Kok Tsui |
|---|---|
| Province | Hong Kong |
| Address | Rm 509 5/F THE CLOUD 111 TUNG CHAU ST |
| Postal code | 999077 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Enzyme Immunoassay, Amphetamine | Class 2 | Accurature Multi-drug Urine Test Dip Card, Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, | 2024 | 16 |
| Enzyme Immunoassay, Barbiturate | Class 2 | Accurature Multi-drug Urine Test Dip Card, Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, | 2024 | 12 |
| Enzyme Immunoassay, Benzodiazepine | Class 2 | Accurature Multi-drug Urine Test Dip Card, Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, | 2024 | 13 |
| Enzyme Immunoassay, Cannabinoids | Class 2 | Accurature Multi-drug Urine Test Dip Card, Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, | 2024 | 18 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Class 2 | Accurature Multi-drug Urine Test Dip Card, Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, | 2024 | 16 |
| Enzyme Immunoassay, Methadone | Class 2 | Accurature Multi-drug Urine Test Dip Card, Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, | 2024 | 11 |
| Enzyme Immunoassay, Opiates | Class 2 | Accurature Multi-drug Urine Test Dip Card, Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, | 2024 | 17 |
| Enzyme Immunoassay, Phencyclidine | Class U | Accurature Multi-drug Urine Test Dip Card, Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, | 2024 | 16 |
| Enzyme Immunoassay, Propoxyphene | Class 2 | Accurature Multi-drug Urine Test Dip Card, Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, | 2024 | 10 |
| Gas Chromatography, Methamphetamine | Class 2 | Accurature Multi-drug Urine Test Dip Card, Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, | 2024 | 10 |
| Strip, Test Isoniazid | Class U | Strip, Test Isoniazid | 2026 | 1 |
Clearances
No clearance names Hongkong Conlight Medical Group Limited as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232228 | 2024-02-23 | DJG | Traditional | Shanghai Accurature Diagnostics Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2015 |
|---|---|
| Employees | 300+ |
| Factory area | 8000 square meters (laboratory) |
| Main products | Drug test kits, Water test kits, Infectious disease test kits, Urine test strips, Lead test kits |
| Certifications | ISO 15189, CAP quality management, ISO 13485, MDSAP, FDA 510(k), EU CE |
| Export markets | Worldwide |
| OEM and ODM | Offered |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.