Manufacturer registered with FDA
Zhejiang Lidesen Medical Instrument Co., Ltd
Hangzhou, China. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 584 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name Zhejiang Lidesen 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 | Zhejiang Lidesen Medical Instrument Co., Ltd | 6 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Zhejiang Lidesen Medical Instrument Co.,Ltd | 33 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ZHEJIANG LIDESEN MEDICAL INSTRUMENT CO., LTD.ZHEJIANG LIDESEN MEDICAL INSTRUMENT CO., LTD | 23 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Zhejiang Lidesen Medical Instrument Co., LtdZhejiang Lidesen Medical Instrument Co., Ltd. | 21 | — | Pure Global AI |
| Tanzania | TMDA | Manufacturer | zhejiang lidesen medical instrument co. ltdZHEJIANG LIDESEN MEDICAL INSTRUMENT CO.,LTD | 7 | 2026–2026 | 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 Lidesen 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 | SALIVA EJECTOR | 2024 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Dental Needle | 2024 |
| Roll CottonEFN · Class 1 | — | Maker | Absorbent cotton pad -NCP , non-woven cotton pad,no-sterile and sterileAbsorbent Cotton Roll, Zig-Zag Cotton Wool, Cotton Pad, Cotton Ball | 2024 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | False tooth boxes with colander insider white | 2025 |
| Oral Hygiene Rubber TipJEW · Class 1 | Floss & interdental cleaners | Maker | digital Thermometer covers | 2025 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | DENTAL BIBS | 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 LIDESEN MEDICAL INSTRUMENT CO., LTDFDA reg. 3031184338 | Hangzhou Zhejiang, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090389). 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.