Manufacturer registered with FDA
Shanghai Maxflex Medical Technology Co., Ltd.
Shanghai, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 76
- 510(k) clearances
- 0as applicant
- Markets registered in
- 710 registrations outside the US
- Establishments
- 1China
Registered in 7 markets
Where regulators' registries name Shanghai Maxflex Medical Technology Co., Ltd. as the manufacturer or the registration holder of a device.
RegisteredHome: ChinaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Shanghai Maxflex Medical Technology Co., Ltd. | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Shanghai Maxflex Medical Technology Co., Ltd. | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Shanghai Maxflex Medical Technology Co Ltd | 2 | 2025–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SHANGHAI MAXFLEX MEDICAL TECHNOLOGY CO. , LTD. | 2 | 2024–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | SHANGHAI MAXFLEX MEDICAL TECHNOLOGY CO., LTD. | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Shanghai Maxflex Medical Technology Co.,Ltd. | 1 | 2026–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Shanghai Maxflex Medical Technology Co., Ltd. | 1 | 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 Shanghai Maxflex Medical 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 Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Thermoforming sheet: D-LMEA-370-F120-130-H D-LMEA-460-F120-100-H D-LMEA-550-F120-200-H D-LMEA-370-F125-130-HThermoforming sheet: D-LMEA-460-F125-100-H D-LMEA-550-F125-200-H D-LMEA-550-F125-060-EThermoforming sheet: M-EC-100-F120-050-C M-EC-100-F125-100-N M-EC-100-F125-076-N M-EC-100-F125-063-NThermoforming sheet: M-EC-100-F120-050-E M-EC-100-F120-063-E M-EC-100-F120-040-CThermoforming sheet: M-EC-100-F120-076-E M-EC-100-F120-040-NThermoforming sheet: M-EC-100-F120-076-N M-EC-100-F120-063-N M-EC-100-F120-100-EThermoforming sheet: M-EC-100-F125-040-N M-EC-100-F125-100-EThermoforming sheet: M-EC-100-F125-063-E M-EC-100-F125-050-E M-EC-100-F125-050-CThermoforming sheet: M-EC-100-F133-076-E M-EC-100-F133-100-E M-EC-100-F133-063-EThermoforming sheet: M-EC-100-S102-100-E M-EC-100-S102-076-E M-EC-100-S127-100-N 66 moreThermoforming sheet: M-EC-100-S102-100-N M-EC-100-S102-076-NThermoforming sheet: M-EC-100-S127-076-N M-EC-100-S127-100-EThermoforming sheet: M-EC-BA1-F120-076-E M-EC-BA1-F120-100-NThermoforming sheet: M-EC-BA1-F120-100-E M-EC-BA1-F125-076-EThermoforming sheet: M-EC-BW1-100-F125-050-C M-EC-BW1-100-F125-063-E M-EC-BW1-100-F125-076-EThermoforming sheet: M-EC-BW1-100-F125-100-E M-LA-100-F120-076-E M-LA-100-F120-063-EThermoforming sheet: M-EC-BW1-F120-050-E M-EC-BW1-F125-050-N M-EC-BW1-F125-050-CThermoforming sheet: M-LA-100-F120-040-C M-LA-100-F120-100-EThermoforming sheet: M-LA-100-F125-040-N M-LA-100-F125-050-NThermoforming sheet: M-LA-100-F125-063-E M-LA-100-F133-100-N M-LA-100-F133-040-CThermoforming sheet: M-LA-100-F125-063-N M-LA-100-F125-076-N M-LA-100-F125-076-E M-LA-100-F125-100-NThermoforming sheet: M-LA-100-F133-050-C M-LA-100-F133-063-E M-LA-100-F133-076-EThermoforming sheet: M-LE-100-F125-076-N M-LE-100-F125-076-E M-LE-100-F125-100-E M-LE-100-F133-076-EThermoforming sheet: M-LE-100-F133-076-N T-DAEA-181-F120-076-NThermoforming sheet: T-DAEA-181-F120-063-N T-DAEA-181-F125-076-N T-DAEA-181-F125-063-N T-DALA-181-F120-076-NThermoforming sheet: T-DALA-181-F120-063-N T-DALA-181-F120-100-E T-DALA-181-F120-100-NThermoforming sheet: T-DALA-181-F125-076-N T-DALA-181-F125-063-NThermoforming sheet: T-DALA-181-F133-100-N T-EADA-111-F125-076-NThermoforming sheet: T-EADA-111-F125-089-E T-EADA-111-F125-100-NThermoforming sheet: T-EADA-111-F133-076-E T-EADA-111-F133-089-NThermoforming sheet: T-EADA-111-F133-089-E T-EADA-111-F133-100-N T-EADA-111-F133-100-EThermoforming sheet: T-EADA-111-R102-076-N T-EADA-111-R102-076-EThermoforming sheet: T-EADA-111-R105-076-N T-EADA-111-R105-076-EThermoforming sheet: T-EADA-111-R137-076-N T-EADA-111-R137-076-EThermoforming sheet: T-EADA-111-S102-089-E T-EADA-111-S102-100-N T-EADA-111-S102-100-E T-EADA-111-S127-076-NThermoforming sheet: T-EADA-111-S127-076-E T-EADA-111-S127-089-NThermoforming sheet: T-EADA-111-S127-089-E T-EADA-111-S127-100-NThermoforming sheet: T-ECDA-343-F120-063-E T-ECDA-343-F120-100-EThermoforming sheet: T-ECDA-343-F120-063-N T-ECDA-343-F120-076-EThermoforming sheet: T-ECDA-343-F120-076-P T-ECDA-343-F120-063-P T-ECDA-343-F120-100-PThermoforming sheet: T-ECDA-343-F125-063-E T-ECDA-343-F125-100-EThermoforming sheet: T-ECDA-343-F125-076-E T-ECDA-343-F125-076-KThermoforming sheet: T-ECDA-343-F125-089-N T-ECDA-343-F133-076-KThermoforming sheet: T-ECDA-343-F125-100-K T-ECDA-343-F125-089-EThermoforming sheet: T-ECDA-343-F125-100-N T-ECDA-343-F125-063-NThermoforming sheet: T-ECDA-343-F133-063-EThermoforming sheet: T-ECDA-343-F133-063-K T-ECDA-343-F133-100-KThermoforming sheet: T-ECDA-343-F133-076-E T-ECDA-343-F133-063-PThermoforming sheet: T-ECDA-343-F133-076-P T-ECDA-343-F133-100-PThermoforming sheet: T-ECDA-343-F133-089-E T-ECDA-343-S102-100-NThermoforming sheet: T-ECDA-343-F133-100-E T-ECDA-343-F133-089-NThermoforming sheet: T-ECDA-343-R102-076-N T-ECDA-343-R102-076-EThermoforming sheet: T-ECDA-343-R105-076-N T-ECDA-343-R105-076-EThermoforming sheet: T-ECDA-343-R137-076-N T-ECDA-343-R137-076-EThermoforming sheet: T-ECDA-343-S102-076-E T-ECDA-343-S102-076-NThermoforming sheet: T-ECDA-343-S102-089-E T-ECDA-343-S102-089-NThermoforming sheet: T-ECDA-343-S127-076-N T-ECDA-343-S127-100-EThermoforming sheet: T-ECDA-343-S127-089-E T-ECDA-343-S127-089-NThermoforming sheet: T-ECDA-343-S127-100-N T-ECDA-343-S127-076-EThermoforming sheet:M-CS-100-F125-070-N M-EC-100-F120-100-NThermoforming sheet:M-EC-100-F125-076-E M-EC-100-F125-040-CThermoforming sheet:M-EC-100-F133-040-C M-EC-100-F133-050-CThermoforming sheet:M-EC-100-S127-076-E M-EC-BA1-F120-076-NThermoforming sheet:M-EC-BA1-F125-100-E M-EC-BW1-F120-050-NThermoforming sheet:M-LA-100-F125-040-C M-LA-100-F125-100-EThermoforming sheet:M-LA-100-F133-100-E M-LE-100-F125-063-NThermoforming sheet:T-DALA-181-F125-100-E T-DALA-181-F125-100-N T-DALA-181-F133-100-EThermoforming sheet:T-EADA-111-F125-076-E T-EADA-111-F125-089-NThermoforming sheet:T-EADA-111-F125-100-E T-EADA-111-F133-076-NThermoforming sheet:T-EADA-111-S102-076-N T-EADA-111-S102-076-E T-EADA-111-S102-089-NThermoforming sheet:T-EADA-111-S127-100-E T-ECDA-343-F120-100-NThermoforming sheet:T-ECDA-343-F120-063-K T-ECDA-343-F120-100-KThermoforming sheet:T-ECDA-343-F120-076-K T-ECDA-343-F120-076-NThermoforming sheet:T-ECDA-343-F125-063-P T-ECDA-343-F125-100-P T-ECDA-343-F125-063-KThermoforming sheet:T-ECDA-343-F125-076-N T-ECDA-343-F125-076-PThermoforming sheet:T-ECDA-343-S102-100-E | 2026 |
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 |
|---|---|---|
| SHANGHAI MAXFLEX MEDICAL TECHNOLOGY CO., LTD.FDA reg. 3044905088 | Shanghai, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10095404). 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.