HUA YUE Medical Technology Co., Ltd.
Manufacturer and brand owner in Guangzhou, Guangdong, China. 7 device types, 7 products catalogued, 2 clearances.
HUA YUE Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Labware, Assisted Reproduction, Accessory, Assisted Reproduction and 5 other device types. 7 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2024.
7device types registered with the FDA
7products catalogued under its own name
2510(k) clearances
Registration
| Registered name | HUA YUE MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3031594904 |
| FEI number | 3031594904 |
| DUNS | 625413598 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 广州市华粤行医疗科技有限公司 |
|---|---|
| Unified social credit code | 91440101MA5AKFYU7R |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | First Floor, C2 building, No.11 Kaiyuan Road, Huangpu District |
| Postal code | 510530 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Assisted Reproduction | Class 2 | Hariomed Humidification Box, Time-lapse Incubator Capacity Expansion Module, Hariomed Culture Dish, Harioculture TL-16 Time-lapse Incubator | 2025 | 4 |
| Accessory, Assisted Reproduction, Exempt | Class 2 | Benchtop Incubator(Model IBI-D101,Harioculture DI-4, Harioculture HI-2, Harioculture HI-4) | 2024 | 3 |
| Assisted Reproduction Laminar Flow Workstation | Class 2 | IVF Workstation | 2024 | 2 |
| Labware, Assisted Reproduction | Class 2 | Hariomed Humidification Box, Time-lapse Incubator Capacity Expansion Module, Hariomed Culture Dish, Harioculture TL-16 Time-lapse Incubator | 2025 | 10 |
| Micromanipulators And Microinjectors, Assisted Reproduction | Class 2 | Micromanipulator System (Model IMS-320D, IMS-320D-S, IMS-320U, IMS-320U-S) | 2024 | 3 |
| Microscope And Microscope Accessories, Reproduction, Assisted | Class 1 | Hariomed Humidification Box, Time-lapse Incubator Capacity Expansion Module, Hariomed Culture Dish, Harioculture TL-16 Time-lapse Incubator | 2025 | 4 |
| System, Assisted Reproduction Laser | Class 2 | Assisted Reproduction Laser System (Model ILS-400M) | 2026 | 1 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Hariomed | QKH | 8 |
| Hariomed | PUB | 4 |
| Hariomed | MQJ | 4 |
| Hariomed culture dish | MQK | 1 |
| Time-lapse Incubator Capacity Expansion Module | MQG | 1 |
| Harioculture TL-16 Time-lapse Incubator | MQG | 1 |
| Hariomed humidification box | MQK | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253333 | 2026-06-17 | MRX | Traditional | This company |
| K242684 | 2025-05-22 | MQG | Traditional | This company |
Nearby Manufacturers
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.