Manufacturer registered with FDA
Zhejiang Mediunion Healthcare Group Co Ltd
NINGBO, China. Lists 11 dental device types with FDA across 1 registered establishment.
- Device types listed
- 11
- Brands and models
- 15
- 510(k) clearances
- 0as applicant
- Markets registered in
- 883 registrations outside the US
- Establishments
- 1China
Registered in 8 markets
Where regulators' registries name Zhejiang Mediunion Healthcare Group 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 | Zhejiang Mediunion Healthcare Group Co Ltd | 11 device types | — | Below |
| European Union | EUDAMED | Manufacturer | ZHEJIANG MEDIUNION HEALTHCARE GROUP CO.,LTD. | 47 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Zhejiang Mediunion Healthcare Group Co Ltd | 16 | 2016–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ZHEJIANG MEDIUNION HEALTHCARE GROUP CO.,LTD,ZHEJIANG MEDIUNION HEALTHCARE GROUP CO, LTD | 11 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Zhejiang Mediunion Healthcare Group Co.,Ltd | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ZHEJIANG MEDIUNION HEALTHCARE GROUP CO. LTD | 3 | 2019–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Zhejiang Mediunion Healthcare Group Co.,Ltd | 1 | 2020–2020 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Zhejiang Mediunion Healthcare Group Co. 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 Zhejiang Mediunion Healthcare Group 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 | Evergrand Saliva Ejector | 2007 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | dental mirror | 2016 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Evergrand Glass Syringe,Water syring tips | 2007 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | EVERGRAND TOOTHBRUSH | 2007 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Bite Blocks | 2016 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | dental cup | 2011 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Dental suction tip | 2016 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | bibs, aprons, dental bib, paper bib, paper apron, plastic bib,exam paper roll | 2014 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | ORAL IRRIGATION DENTALUNIT | 2016 |
| Patient Personal Hygiene KitNSB · Class 1 | — | Maker | EVERGRAND ADMIT KIT | 2007 |
| Dental Hygiene KitNXZ · Class 1 | — | Maker | Dental hygiene kitpill boxplastic boxSilicone Nipples | 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 |
|---|---|---|
| ZHEJIANG MEDIUNION HEALTHCARE GROUP CO.,LTDFDA reg. 3006210673 | Ningbo Zhejiang, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9103599). 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.