FDA Registration
Active
🇰🇷 South Korea
MEDIANA CO., LTD.
Reg #: 3003591740
·
FEI: 3003591740
·
Expires 2026
Products
13
Proprietary Names
30
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- MEDIANA CO., LTD.
- Registration Number
- 3003591740
- FEI Number
- 3003591740
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 132, Donghwagongdan-ro, Munmak-eup
- City
- Wonju-Si, Gangwon-do
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K082812
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 |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2010-08-16 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2010-08-16 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2010-08-16 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2010-08-16 |
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2019-10-31 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2016-06-29 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2010-07-01 |
| Computer, Blood-Pressure | DSK | 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 |
| Camera, Television, Endoscopic, Without Audio | FWF | Class 1 | General, Plastic Surgery | No | 2016-10-13 |
| Microscope, Surgical, General & Plastic Surgery | FSO | Class 1 | General, Plastic Surgery | No | 2016-10-13 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-06-15 |
Proprietary Names
VITAL SIGNS MONITOR
S207
MODEL HBP-2070
MULTIPLE NAMES USED
N-560
I20,I30, I25, I35, I50, I55
Body Composition Analyzer
Diagnostic Ultrasuond System
Lucon M-series (M20, M30)
Patient Monitor
Nellcor Bedside SpO2 Patient Monitoring System (PM100N)
V10
AVSM2
AVSM i
BP S510 Colin Press Mate
Insight-One
Insight-I
PATIENT MONITOR,YM6000
YM1000
AVM-1
ARGUS VCM SERIES
HBP-T105
DT-100
Insight-micro+
Model 91220
Vital Sign Monitors, V20, V20a, AVSM3 SNF
Nellcor Potable SpO2 Patient Monitoring System
Nellcor Bedside SpO2 Patient Monitoring System
NBSPMS
Mediana Face Mask
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)