Data / Medical devices / China / Guangdong Yuehua Medical Instrument Factory Co., Ltd.
Guangdong Yuehua Medical Instrument Factory Co., Ltd.: FDA-registered device maker in Shantou Guangdong, China, 1 510(k) clearance
Guangdong Yuehua Medical Instrument Factory Co., Ltd. is registered with the FDA (registration 3004475699) in Shantou Guangdong, China. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 26, 2002. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004475699
- Address
- Rongsheng Science & Technology Zone Daxue Rd., Shantou Guangdong, China, 515063
- Owner or operator
- Guangdong Yuehua Medical Instrument Factory Co., Ltd. (10039189)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- December 15, 2011
- Registered through
- 2026
- Brand names listed
- Alternating Pressure Mattress, Anti-decubitus Cushion, Cassette, Mattress Cover, Shampoo basin, X-Ray Film Illuminator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Hygiene | ILS | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cassette, Radiographic Film | IXA | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cover, Mattress (Medical Purposes) | FMW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cushion, Flotation | KIC | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Illuminator, Radiographic-Film | IXC | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mattress, Air Flotation, Alternating Pressure | FNM | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mattress, Flotation Therapy, Non-Powered | IKY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 26, 2002 | K023020 | AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE | IXA | Substantially Equivalent | Agfa Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Cover, Mattress (Medical Purposes)
- All makers of Mattress, Air Flotation, Alternating Pressure
- All makers of Cassette, Radiographic Film
- All makers of Illuminator, Radiographic-Film
- All makers of Adaptor, Hygiene
- All makers of Cushion, Flotation
Updated September 26, 2002. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.