Data / Medical devices / Hong Kong / Amsino Medical Group (HK) Company Limited
Amsino Medical Group (HK) Company Limited: FDA-registered device maker in Hong Kong, Hong Kong, 5 510(k) clearances
Amsino Medical Group (HK) Company Limited is registered with the FDA (registration 3012445205) in Hong Kong, Hong Kong. It lists 11 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 10, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012445205
- Address
- 9th Floor, Tung Ning Building, Des Voeux Road Central, Hong Kong, Hong Kong, 999077
- Owner or operator
- Amsino Medical Group (HK) Company Limited (10061664)
- Roles
- Exporter to the US
- First device listed
- November 7, 2019
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | 2 | Exporter to the US | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Exporter to the US | accessdata.fda.gov |
| Catheter, Ureteral, Gastro-Urology | EYB | 2 | Exporter to the US | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Exporter to the US | accessdata.fda.gov |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | 2 | Exporter to the US | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Exporter to the US | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Exporter to the US | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Exporter to the US | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Exporter to the US | accessdata.fda.gov |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | 2 | Exporter to the US | accessdata.fda.gov |
| Tube, Aspirating, Flexible, Connecting | BYY | 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 |
|---|---|---|---|---|---|---|
| March 10, 2010 | K093773 | AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS | FPA | Substantially Equivalent | Amsino International, Inc. | accessdata.fda.gov |
| October 23, 2008 | K082831 | AMSELF CLOSED CATHETERIZATION SYSTEM | FCM | Substantially Equivalent | Amsino International, Inc. | accessdata.fda.gov |
| February 4, 2004 | K030293 | AMSURE RED RUBBER URETHRAL CATHETER | EYB | Substantially Equivalent | Amsino International, Inc. | accessdata.fda.gov |
| May 23, 2003 | K030712 | AMSURE URETHRAL CATHETERIZATION TRAY | FCM | Substantially Equivalent | Amsino International, Inc. | accessdata.fda.gov |
| May 23, 2003 | K030664 | AMSURE FOLEY INSERTION TRAY | FCM | Substantially Equivalent | Amsino International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter And Tip, Suction
- All makers of Container, Specimen, Non-Sterile
- All makers of Catheter, Ureteral, Gastro-Urology
- All makers of Tube, Aspirating, Flexible, Connecting
- All makers of Set, Administration, Intravascular
- All makers of Catheters, Suction, Tracheobronchial
Updated March 10, 2010. 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.