AR Medicom Inc., (Asia), Ltd.
Registered establishment in Hongkong, Hong Kong, China. 5 device types.
AR Medicom Inc., (Asia), Ltd. is an exporter holding a current FDA establishment registration. The registration covers Mask, Surgical, Absorber, Saliva, Paper and 3 other device types. Its earliest product listing with the FDA dates from 1996.
Registration
| Registered name | AR MEDICOM INC., (ASIA), LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3003230618 |
| FEI number | 3003230618 |
| Establishment type | Exporter |
Location
| City | Hongkong |
|---|---|
| Province | Hong Kong |
| Address | Suite 11,11/F, Kodak House II |
| Postal code | — |
| Country | China |
Group
AR Medicom Inc., (Asia), Ltd. is one of 2 plants registered under Medicom Group.
| Plant | City | Device types |
|---|---|---|
| A.R. Medicom Inc. (Shanghai) Co., Ltd. | Shanghai | 4 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorber, Saliva, Paper | Class 1 | DISTECH Dental Bibs, SAFE GAUZE Dental Bibs, MEDICOM Dental Bibs | 2005 | 86 |
| Chair, Dental, Without Operative Unit | Class 1 | Medicom, Head Rest Covers | 2005 | 38 |
| Mask, Surgical | Class 2 | Medicom SafeBasics, Medicom SafeMask, Medicom AssureMask | 1996 | 125 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Safe+Mask Protective Eyewear | 2008 | 384 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | Class 2 | Medicom Sterilization Pouches & Reels, Pouches & Reels | 2001 | 5 |
Clearances
No clearance names AR Medicom Inc., (Asia), Ltd. as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K070428 | 2007-07-17 | KCT | Traditional | A.R. Medicom, Inc. |
| K051291 | 2005-09-20 | FXX | Traditional | A.R. Medicom, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1988 |
|---|---|
| Employees | 2000+ |
| Main products | Masks, Gloves, Protective apparel, Disinfectants, Surgical solutions |
| Certifications | ISO 13485:2016 |
| Export markets | 95+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Arrow Medsource Group Limited | 17 |
| Ecollink NON-Woven Company Limited | 14 |
| Natural Dental Laboratory Co., Limited | 10 |
| Hansion Eyewear Manufactory Co., Limited | 4 |
| Hong Kong Summit Limited | 4 |
| Nature Health Trading (Hong Kong) Co., Limited | 1 |
| Comepa Industries Limited | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.