FDA Registration
Active
🇹🇼 Taiwan
EZYPRO ECG Recorder
Reg #: 3025330366
·
FEI: 3025330366
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SIGKNOW BIOMEDICAL CO., LTD.
- Registration Number
- 3025330366
- FEI Number
- 3025330366
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Floor 6, No. 760, Sec. 4, Bade Road, Songshan District
- City
- Taipei City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K213233
Owner / Operator
- Firm Name
- Sigknow Biomedical Co., Ltd.
- Operator Number
- 10086189
- Address
- Floor 6, No. 760, Sec. 4, Bade Road, Songshan District
- City
- Taipei City
- State
- TW-TPE
- Postal Code
- 105
- Country
- TW
- Correspondent
- Alan Wu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2022-10-20 |
Proprietary Names
EZYPRO ECG Recorder
Establishment Types
Manufacture Medical Device