FDA Registration
Active
🇰🇷 South Korea
THE STANDARD CO., LTD.
Reg #: 3013734919
·
FEI: 3013734919
·
Expires 2026
Products
6
Proprietary Names
18
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- THE STANDARD CO., LTD.
- Registration Number
- 3013734919
- FEI Number
- 3013734919
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 120, Gunpocheomdansaneop 2-ro
- City
- Gunpo-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K241591
Owner / Operator
- Firm Name
- The Standard Co., Ltd.
- Operator Number
- 10055479
- Address
- 120, Gunpocheomdansaneop 2-ro
- City
- Gunpo-si
- State
- Gyeonggi
- Postal Code
- 15880
- Country
- KR
- Correspondent
- Boyeon Cho
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 |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2024-10-10 |
| Submucosal Injection Agent | PLL | Class 2 | Gastroenterology, Urology | No | 2024-07-04 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2022-09-05 |
| Marker, Colon | NBG | Class 2 | Gastroenterology, Urology | No | 2017-07-28 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2024-10-10 |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2024-10-10 |
Proprietary Names
SILKRO
ASCENDO submucosal lifting agent-10mL (Model Name : 00712935)
ASCENDO submucosal lifting agent-5mL (Model Name : 00712934)
Blue Eye (TS-910)
SOUNDSTAR 3D G (SNDSTR10G)
AcuNav 8F ultrasound catheter
AcuNav 10F ultrasound catheter
AcuNav 8F ultrasound catheter (GE)
AcuNav 10F ultrasound catheter (GE)
Acunav Crystal Ultrasound Catheter
SOUNDSTAR 3D (SNDSTR10)
SOUNDSTAR eco 8F (10439011) & 8F G (10439236)
SOUNDSTAR eco 10F (10438577) & 10F G (10439072)
Black Eye
Endoscopic Marker (Model Name : 00711836)
A-FIT
Acuson Acunav Volume Intracardiac Echocardiography(Ice) Catheter
Blue Eye
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device