FDA Registration
Active
🇰🇷 South Korea
ACE MEDICAL INDUSTRy CO., LTD.
Reg #: 3019012929
·
FEI: 3019012929
·
Expires 2026
Products
3
Proprietary Names
7
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ACE MEDICAL INDUSTRy CO., LTD.
- Registration Number
- 3019012929
- FEI Number
- 3019012929
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 57-14 , Gwangjeok ro 228beon gil, Gwang jeok myeon
- City
- Yangju-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K200017
Owner / Operator
- Firm Name
- Ace Medical Industry Co., Ltd.
- Operator Number
- 10081789
- Address
- 57-14 , Gwangjeok ro 228beon gil, Gwang jeok myeon
- City
- Yangju-si
- State
- Gyeonggi
- Postal Code
- 11414
- Country
- KR
- Correspondent
- Won Bae Joe
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2021-05-16 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2021-05-16 |
| Needle, Acupuncture, Single Use | MQX | Class 2 | General Hospital | No | 2025-05-27 |
Proprietary Names
ACE Cannula
DermaFlex Aspiration Needle
Cannulall
Q Micro Cannula
Eclipse DermaFlex MicroCannula
Duo Cannula
ACE MESO THERAPIE
Establishment Types
Manufacture Medical Device