Manufacturer registered with FDA
Yiwu Jiekang Medical Articles Co., Ltd.
YIWU, ZHEJIANG, China. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 46 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name Yiwu Jiekang Medical Articles 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 | Yiwu Jiekang Medical Articles Co., Ltd. | 4 device types | — | Below |
| Taiwan | TFDA | Manufacturer | YIWU JIEKANG MEDICAL ARTICLES CO., LTD. | 3 | 2007–2016 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | YIWU JIEKANG MEDICAL ARTICLES CO LTDYIWU JIEKANG MEDICAL ARTICLES CO., LTD. | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | YIWU JIEKANG MEDICAL ARTICLES CO., LTD. | 1 | 2004–2004 | 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 Yiwu Jiekang Medical Articles 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 |
|---|---|---|---|---|
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Syringe Sleeves, Syring Tip Cover | 2007 |
| Roll CottonEFN · Class 1 | — | Maker | Cotton Rolls | 2009 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Patient Bibs | 2009 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Barrier Sleeves | 2007 |
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 |
|---|---|---|
| YIWU JIEKANG MEDICAL ARTICLES CO., LTD.FDA reg. 3005688007 | YIWU, ZHEJIANG, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9085801). 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.