FDA Registration
Active
🇹🇼 Taiwan
ATOM HEALTH CORPORATION
Reg #: 3014498861
·
FEI: 3014498861
·
Expires 2026
Products
9
Proprietary Names
2
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- ATOM HEALTH CORPORATION
- Registration Number
- 3014498861
- FEI Number
- 3014498861
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1F., No. 29, Minsheng 6th St., Guiren Dist.,
- City
- Tainan City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K113239
Owner / Operator
- Firm Name
- ATOMHEALTH Corporation
- Operator Number
- 10057545
- Address
- 4FL.-3, No.112, Sec.2, Zhongshan North Road
- City
- Zhongshan Dist., Taipei City
- State
- TW-TPE
- Postal Code
- 104
- Country
- TW
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2022-11-11 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2018-12-18 |
| Collector, Urine, Powered, Non Indwelling Catheter | NZU | Class 1 | Gastroenterology, Urology | No | 2026-04-13 |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | Class 2 | Gastroenterology, Urology | No | 2022-11-11 |
| Catheter, Straight | EZD | Class 2 | Gastroenterology, Urology | No | 2018-12-18 |
| Catheter, Coude | EZC | Class 2 | Gastroenterology, Urology | No | 2018-12-18 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-05-12 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2019-12-23 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-05-23 |
Proprietary Names
CompactCath
MOCACARE
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)