Manufacturer registered with FDA
Changzhou Shengkang Medical Instrument Co.,LTD
Changzhou, China. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 622 registrations outside the US
- Establishments
- 1China
Registered in 6 markets
Where regulators' registries name Changzhou Shengkang Medical Instrument 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 | Changzhou Shengkang Medical Instrument Co.,LTD | 8 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Changzhou Shengkang Medical Instrument Co., Ltd. | 13 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CHANGZHOU SHENGKANG MEDICAL INSTRUMENT CO., LTD. | 4 | 2016–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Changzhou Shengkang Medical Instrument Co.,Ltd | 3 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | CHANGZHOU SHENGKANG MEDICAL INSTRUMENT CO., LTD. | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | CHANGZHOU SHENGKANG MEDICAL INSTRUMENT CO.,LTD | 1 | 2019–2019 | 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 Changzhou Shengkang Medical Instrument 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 | Disposable dental saliva ejector | 2026 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Disposable dental irrigation needles | 2026 |
| Roll CottonEFN · Class 1 | — | Maker | Disposable dental cotton rolls | 2026 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Polishing brush | 2026 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Dental tray | 2026 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Air water syringe tip | 2026 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Disposable dental mirror | 2026 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | Disposable dental probe | 2026 |
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 |
|---|---|---|
| CHANGZHOU SHENGKANG MEDICAL INSTRUMENT CO.,LTDFDA reg. 3012922212 | Changzhou Jiangsu, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10095334). 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.