Manufacturer registered with FDA
Changzhou Ou Nuo Medical Equipment Co., Ltd.
Changzhou City, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- 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 Changzhou Ou Nuo Medical Equipment 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 | Changzhou Ou Nuo Medical Equipment Co., Ltd. | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Changzhou Ou Nuo Medical Equipment Co., Ltd. | 1 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Changzhou Ou Nuo Medical Equipment Co., Ltd. | 1 | 2026–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Changzhou Ou Nuo Medical Equipment 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 Changzhou Ou Nuo Medical Equipment 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 |
|---|---|---|---|---|
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | C150, C200, MUL063, MUL076, MUL100, MUL150, MUL175, MUL200, MUL250, MUL300, MUL350, MUL400, MUL450, MUL500, MUL076 Pro,Dental Sheet/Dental Roll: T040RC125N, T050RC125N, T063RC125N, T076RC125N, T088RC125N, T100RC125N, T040MC125N,MUL076 Lux, C050 Pro.T050MC125N, T063MC125N, T076MC125N, T088MC125N, T100MC125N, T040RS125N, T050RS125N, T063RS125N, T076RS125N, T088RS125N,T063, T076, T088, T100, T150, T200, P040, P050, P063, P076, P088, P100, P150, P200, C040, C050, C063, C076, C088, C100,T076RS120N, T088RS120N, T100RS120N, T040MS120N, T050MS120N, T063MS120N, T076MS120N, T088MS120N, T100MS120N, T040, T050,T100RS125N, T040MS125N, T050MS125N, T063MS125N, T076MS125N, T088MS125N, T100MS125N, T040RS120N, T050RS120N, T063RS120N, | 2023 |
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 |
|---|---|---|
| CHANGZHOU OU NUO MEDICAL EQUIPMENT CO., LTD.FDA reg. 3026326475 | Changzhou City Jiangsu, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10087154). 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.