Registered with FDA
Zhejiang Medicines & Health Products Import & Expo
HANGZHOU, ZHEJIANG, China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 43 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name Zhejiang Medicines & Health Products Import & Expo as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Zhejiang Medicines & Health Products Import & Expo | 3 device types | — | Below |
| Brazil | ANVISA | Manufacturer | ZHEJIANG MEDICINES & HEALTH PRODUCTS I/E CO.LTD. | 1 | 2015–2015 | Pure Global AI |
| Israel | AMAR | Manufacturer | Zhejiang Medicines & Health Products I/E Co., Ltd. | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ZHEJIANG MEDICINES & HEALTH PRODUCTS I/E CO.,LTD. | 1 | 2008–2008 | 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 Zhejiang Medicines & Health Products Import & Expo currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Roll CottonEFN · Class 1 | — | Lister | Absorbent Cotton WoolCotton BallsCotton Roll | 2021 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Lister | IRRIGATING SYRINGE, BULB SYRINGE, 50ML, 60ML, 100ML | 2025 |
| Paper Saliva AbsorberKHR · Class 1 | — | Lister | CREPE PAPER all sizesDENTAL APRON, BIBSSTERILIZATION PAPER all sizes | 2012 |
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 |
|---|---|---|
| ZHEJIANG MEDICINES & HEALTH PRODUCTS I/ E CO., LTD.FDA reg. 9680222 | HANGZHOU, ZHEJIANG, China | Foreign exporter |
Other names on FDA records
Zhejiang Medicines & Health Products I/E Co.,ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9007317). 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.