FDA Registration
Active
🇰🇷 South Korea
All Medicus Co., Ltd.
Reg #: 3007363438
·
FEI: 3005664575
·
Expires 2026
Products
6
Proprietary Names
15
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- All Medicus Co., Ltd.
- Registration Number
- 3007363438
- FEI Number
- 3005664575
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.7102-7107,7402,7403,7406, 140, Beolmal-ro, Dongan-gu
- City
- Anyang-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K220475
Owner / Operator
- Firm Name
- All Medicus Co., Ltd
- Operator Number
- 10027562
- Address
- #7609, 140, Beolmal-ro, Dongan-gu
- City
- Anyang
- State
- Gyeonggi
- Postal Code
- 14057
- Country
- KR
- Correspondent
- Hong Joo Park
US Agent
- Business Name
- LK Consulting Group USA, Inc.
- Contact Name
- Priscilla Chung
- Address
- 2552 Walnut Ave Ste 230
- City
- Tustin
- State
- CA
- ZIP
- 92780
- Country
- US
- [email protected]
- Phone
- 714 9225276
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2022-12-23 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2022-12-23 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2009-12-27 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2009-12-27 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2009-12-27 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2021-11-22 |
Proprietary Names
Lancet, Lancing Device
Lancing Device
McKesson Glucose Control Solution
McKesson Blood Glucose Test Strips
Embrace PRO Blood Glucose Test Meter
Embrace PRO Blood Glucose Test Strips
Alere G1 Blood Glucose Monitoring System
GLUCODR AUTO SYSTEM
VICTORY Blood Glucose Monitoring System
Embrace PRO Blood Glucose Monitoring System
McKesson Blood Glucose Monitoring System
Embrace PRO Control Solution
VICTORY
Lancets
metene Blood Glucose Monitoring System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device