Manufacturer registered with FDA
Medicom Group
Pointe Claire, Canada. Lists 2 dental device types with FDA across 3 registered establishments.
- Device types listed
- 2
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 639 registrations outside the US
- Establishments
- 3China, United States
Registered in 6 markets
Where regulators' registries name Medicom Group 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 | Medicom Group | 2 device types | — | Below |
| Taiwan | TFDA | Manufacturer | A. R. MEDICOM INC. (SHANGHAI) CO. LTDA.R. MEDICOM INC.(SHANGHAI)CO., LTD. · UNITED MEDICAL ENTERPRISE INC. · +2 | 17 | 2007–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | A R Medicom Inc Asia LtdA.R. Medicom Inc (Shanghai) Co Ltd | 8 | 2013–2020 | Pure Global AI |
| Hong Kong | MDD | Registration holder | A.R. Medicom Inc. (Asia) Limited | 8 | 2024–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | A. R. Medicom Inc. (Asia) Ltd.A. R. Medicom Inc. (Shanghai) Co., Ltd · A.R. Medicom Inc.(Shanghai) Ltd. | 4 | 2005–2024 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | A.R.Medicom Inc. (Shanghai) Co. Ltd. | 2 | — | 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 Medicom Group currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | DISTECH Dental BibsMEDICOM Dental BibsSAFE GAUZE Dental Bibs | 2005 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | HEAD REST COVERSMEDICOM | 2005 |
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 |
|---|---|---|
| A.R. Medicom Inc. (Shanghai) Co., Ltd.FDA reg. 3006691703 | Shanghai, China | Contract manufacturer |
| AR MEDICOM INC., (ASIA), LTD.FDA reg. 3003230618 | Hongkong Hong Kong, China | Foreign exporter |
| United Medical Enterprise, Inc.FDA reg. 3017949824 | Thomson, GA, United States | Contract manufacturer |
Other names on FDA records
A. R. Medicom Inc. (Asia) Ltd. · A.R. Medicom Inc. (Shanghai) Co., Ltd. · United Medical Enterprise Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9007111). 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.