Manufacturer registered with FDA
美舒博股份有限公司Medsorb Dominicana, S.A.
SAN PEDRO DE MACORIS, Dominican Republic. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1153 registrations outside the US
- Establishments
- 1Dominican Republic
Registered in 11 markets
Where regulators' registries name 美舒博股份有限公司Medsorb Dominicana, S.A. 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 | 美舒博股份有限公司Medsorb Dominicana, S.A. | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | MEDSORB DOMINICANA S.A. | 21 | 2007–2008 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Medsorb Dominicana, S.A. | 12 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MEDSORB DOMINICANA, S.A. | 6 | 2011–2012 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MEDSORB DOMINICANA, S.A. | 5 | 2007–2017 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Medsorb Dominicana,S.A.MEDSORB DOMINICANA, S.A. | 3 | 1999–2014 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | MEDSORB DOMINICANA, S.A. | 2 | — | Pure Global AI |
| China | NMPA | Registration holder | 美舒博股份有限公司Medsorb Dominicana, S.A. | 1 | — | Pure Global AI |
| Egypt | EDA | Manufacturer | Medsorb Dominicana, S.A.,, | 1 | 2020–2020 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Medsorb Dominicana S.A. | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | MEDSORB DOMINICANA S.A. | 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 美舒博股份有限公司Medsorb Dominicana, S.A. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Roll CottonEFN · Class 1 | — | Maker | DALE MEDICAL PRODUCTSOmnia | 2023 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | — | 2010 |
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 |
|---|---|---|
| MEDSORB DOMINICANA, S.A.FDA reg. 9680271 | SAN PEDRO DE MACORIS, Dominican Republic | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9007830). 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.