Shenb Company, Ltd.
⚠️ Moderate Risk
FEI: 3010226575 • Seongdong-gu, Seoul • SOUTH KOREA
FEI Number
3010226575
Location
Seongdong-gu, Seoul
Country
SOUTH KOREAAddress
148 8th Floor Shenb Bldg., , Seongdong-gu, Seoul, South Korea
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/18/2020 | 79OUHSKIN RESURFACING RF APPLICATOR | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 5/18/2020 | 79OUHSKIN RESURFACING RF APPLICATOR | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 5/18/2020 | 79OUHSKIN RESURFACING RF APPLICATOR | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 5/17/2020 | 79OUHSKIN RESURFACING RF APPLICATOR | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 5/17/2020 | 79OUHSKIN RESURFACING RF APPLICATOR | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 4/11/2019 | 80NRWSTIMULATOR, INTRAMUSCULAR, AUTOMATIC | 341REGISTERED | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Shenb Company, Ltd.'s FDA import refusal history?
Shenb Company, Ltd. (FEI: 3010226575) has 6 FDA import refusal record(s) in our database, spanning from 4/11/2019 to 5/18/2020.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Shenb Company, Ltd.'s FEI number is 3010226575.
What types of violations has Shenb Company, Ltd. received?
Shenb Company, Ltd. has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Shenb Company, Ltd. come from?
All FDA import refusal data for Shenb Company, Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.