Manufacturer registered with FDA
Zhejiang Yamei Medical Equipment Technology Co., Ltd.
Yang Jiao Lang Zin'an Town, China. Lists 27 dental device types with FDA across 1 registered establishment.
- Device types listed
- 27
- Brands and models
- 23
- 510(k) clearances
- 0as applicant
- Markets registered in
- 39 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Zhejiang Yamei Medical Equipment Technology 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 Yamei Medical Equipment Technology Co., Ltd. | 27 device types | — | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | Zhejiang Yamei Medical Equipment Technology co., Ltd. | 8 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Zhejiang Yamei Medical Equipment Technology Co., Ltd. | 1 | 2025–2025 | 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 Yamei Medical Equipment Technology 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 |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Retainer, Screw Expansion, Orthodontic | 2023 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | Saliva Ejector | 2024 |
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Maker | Band.Material. Orthodontic | 2024 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | — | 2023 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | Tube, Orthodontic | 2023 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Dental WedgeMouth Props, Endo Measure Block,Endo Clean Stand | 2024 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Mouth Mirror, Contrastor, Photographic Mirror | 2024 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Disposable Air-Water Syringe Tips, Cover Of Air-Water Syringe Tips,Curved Utility Syringes, HP Mixing Tip | 2024 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Band, Elastic, Orthodontic | 2023 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | — | 2023 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | Clamp, Wire, Orthodontic | 2023 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Denture Brush | 2024 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Orthodontic Wax | 2024 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | X-Ray Holder | 2024 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Prophy Cup Brush | 2024 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Impression Tray Base,Impression Tray | 2024 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Surgical Aspirator Tip | 2024 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Dental Impression Material | 2024 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Cheek Retractors, Mouth Opener | 2024 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Dental Probe | 2024 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | — | 2023 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Prophy Paste | 2024 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | Forceps | 2024 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | — | 2023 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | — | 2023 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Universal Barrier Film,Denture Box | 2024 |
| Patient Personal Hygiene KitNSB · Class 1 | — | Maker | Disposable Dental Instrument Kit | 2024 |
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 YAMEI MEDICAL EQUIPMENT TECHNOLOGY CO., LTD.FDA reg. 3026326493 | Yang Jiao Lang Zin'an Town Zhejiang, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10087161). 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.