Data / Medical devices / China / Heyuan Hong De Medical Products Co., Ltd.
Heyuan Hong De Medical Products Co., Ltd.: FDA-registered device maker in Heyuan City Guangdong, China, 1 510(k) clearance
Heyuan Hong De Medical Products Co., Ltd. is registered with the FDA (registration 3013429557) in Heyuan City Guangdong, China. It lists 13 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 11, 2023. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3013429557
- Address
- 3rd Road Linjiang Industrial Zone Jiangdong New Area, Heyuan City Guangdong, China, 517001
- Owner or operator
- Heyuan Hong De Medical Products Co., Ltd. (10052554)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- August 15, 2016
- Registered through
- 2027
- Brand names listed
- COVER PROBE W/GEL & BANDS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Basin, Emesis | FNY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Blood Pressure Cuff | DXQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | 2 | Contract manufacturer | accessdata.fda.gov |
| Cover, Barrier, Protective | MMP | 2 | Contract manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Contract manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer | accessdata.fda.gov |
| Light, Surgical, Accessories | FTA | 2 | Exporter to the US | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Exporter to the US | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| January 11, 2023 | K221278 | Transducer Probe Cover | ITX | Substantially Equivalent | Hony Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Cover, Shoe, Operating-Room
- All makers of Gown, Surgical
- All makers of Drape, Surgical, Antimicrobial
- All makers of Blood Pressure Cuff
- All makers of Non-Surgical Gown
- All makers of Drape, Surgical, Exempt
Updated January 11, 2023. 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.