Data / Medical devices / China / Ar Medicom Inc., (asia), Ltd.
Ar Medicom Inc., (asia), Ltd.: FDA-registered device maker in Hongkong Hong Kong, China, 2 510(k) clearances
Ar Medicom Inc., (asia), Ltd. is registered with the FDA (registration 3003230618) in Hongkong Hong Kong, China. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 17, 2007. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003230618
- Address
- Suite 11,11/F, Kodak House II 39 Healthy Street East, North Point, Hongkong Hong Kong, China, --
- Owner or operator
- Medicom Group (9007111)
- Roles
- Exporter to the US
- First device listed
- May 1, 1996
- Registered through
- 2027
- Brand names listed
- DISTECH Dental Bibs, HEAD REST COVERS, MEDICOM, MEDICOM Dental Bibs, Medicom AssureMask, Medicom SafeBasics, Medicom SafeMask, Medicom Sterilization Pouches & Reels and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorber, Saliva, Paper | KHR | 1 | Exporter to the US | accessdata.fda.gov |
| Chair, Dental, Without Operative Unit | NRU | 1 | Exporter to the US | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Exporter to the US | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 17, 2007 | K070428 | MEDICOM SELF-SEALING STERILIZATION POUCH | KCT | Substantially Equivalent | A.R. Medicom, Inc. | accessdata.fda.gov |
| September 20, 2005 | K051291 | NON-STERILE SURGICAL MASK | FXX | Substantially Equivalent | A.R. Medicom, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Absorber, Saliva, Paper
- All makers of Mask, Surgical
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Chair, Dental, Without Operative Unit
Updated July 17, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.