Manufacturer registered with FDA
BH Medical Products Co., Ltd
Changzhou City, China. Lists 16 dental device types with FDA across 1 registered establishment.
- Device types listed
- 16
- Brands and models
- 35
- 510(k) clearances
- 0as applicant
- Markets registered in
- 552 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name BH Medical Products Co., Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | BH Medical Products Co., Ltd | 16 device types | — | Below |
| Australia | TGA | Manufacturer | BH Medical Products Co Ltd | 42 | 2017–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | BH MEDICAL PRODUCTS CO., LTD | 7 | 2020–2024 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | BH Medical Products Co.,Ltd | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | BH Medical Products., Ltd | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What BH Medical Products Co., Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | aspirator tipHVE tipsaliva ejector | 2011 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Needle sheath cardneedle sheath prop | 2024 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Wedge | 2015 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | bite trayimpression tray | 2015 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Air/Water Syringe Tips | 2011 |
| Articulation PaperEFH · Class 1 | — | Maker | Articulating paper | 2025 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | Bib Clip | 2025 |
| Roll CottonEFN · Class 1 | — | Maker | cotton rolls | 2011 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | bite-wing tabs | 2024 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Prophy cup | 2023 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | HVE tips | 2011 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | lip ring retractorMouth Prop | 2014 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Micro Brush Applicators | 2015 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Dental Bib | 2015 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | bib holdercartridge gunendo blockendo ringindicator stripindicator tapeIntraoral mixing tipslight protective hand shieldmixing stickspaper wrapper 3 morepatient kitssterilization tapetray cover ritter | 2011 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | headrest coverTray Covertray paper | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BH Medical Products Co., LtdFDA reg. 3009307523 | Changzhou City Jiangsu, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10036911). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.