Data / Medical devices / Taiwan / Atom Health Corporation
Atom Health Corporation: FDA-registered device maker in Tainan City, Taiwan, 4 510(k) clearances
Atom Health Corporation is registered with the FDA (registration 3014498861) in Tainan City, Taiwan. It lists 9 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 16, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014498861
- Address
- 1F., No. 29, Minsheng 6th St., Guiren Dist., Tainan City, Taiwan, 711009
- Owner or operator
- ATOMHEALTH Corporation (10057545)
- Roles
- Contract manufacturer, Exporter to the US
- First device listed
- April 22, 2018
- Registered through
- 2026
- Brand names listed
- CompactCath, MOCACARE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | 1 | Exporter to the US | accessdata.fda.gov |
| Catheter, Coude | EZC | 2 | Exporter to the US | accessdata.fda.gov |
| Catheter, Straight | EZD | 2 | Exporter to the US | accessdata.fda.gov |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | 2 | Exporter to the US | accessdata.fda.gov |
| Collector, Urine, Powered, Non Indwelling Catheter | NZU | 1 | Contract manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Exporter to the US | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Exporter to the US | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Exporter to the US | accessdata.fda.gov |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | 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 |
|---|---|---|---|---|---|---|
| September 16, 2019 | K190507 | Full Automatic (NIBP) Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| June 14, 2018 | K180738 | COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter | EZD | Substantially Equivalent | Compactcath, Inc. | accessdata.fda.gov |
| April 26, 2016 | K160858 | CompactCath Intermittent Urinary Catheter | EZD | Substantially Equivalent | Compactcath, Inc. | accessdata.fda.gov |
| March 16, 2012 | K113239 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF) | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Urinary Drainage Collection Kit, For Indwelling Catheter
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Collector, Urine, (And Accessories) For Indwelling Catheter
- All makers of Bag, Urine Collection, Leg, For External Use, Sterile
- All makers of Catheter, Straight
- All makers of Catheter, Coude
Updated September 16, 2019. 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.