FDA Registration
Active
🇰🇷 South Korea
BP S510 Colin Press Mate
Reg #: 3003591740
·
FEI: 3003591740
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- MEDIANA CO., LTD.
- Registration Number
- 3003591740
- FEI Number
- 3003591740
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 132, Donghwagongdan-ro, Munmak-eup
- City
- Wonju-Si, Gangwon-do
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K063690
Owner / Operator
- Firm Name
- MEDIANA CO., LTD.
- Operator Number
- 9048468
- Address
- 132, Donghwagongdan-ro, Munmak-eup
- City
- Wonju-Si, Gangwon-do
- State
- KR-NOTA
- Postal Code
- 26365
- Country
- KR
US Agent
- Business Name
- IRC USA
- Contact Name
- CHARLES MACK
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938 ext. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2009-03-28 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2009-03-28 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2009-03-28 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2009-03-28 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2009-03-28 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2009-03-28 |
Proprietary Names
BP S510 Colin Press Mate
Establishment Types
Manufacture Medical Device