Jeisys Medical Co., Ltd.
⚠️ Moderate Risk
FEI: 3006985163 • Seoul, Seoul • SOUTH KOREA
FEI Number
3006985163
Location
Seoul, Seoul
Country
SOUTH KOREAAddress
307, 308, 401, 410, Daeryung Techno Town 8th, 96 Gamasan-ro, Geumcheon-gu, , Seoul, 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 REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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 |
|---|---|---|---|
| 10/5/2015 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of West Coast Imports (DWCI) | |
| 4/27/2015 | 79ONGPOWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT | 476NO REGISTR | Division of West Coast Imports (DWCI) |
| 4/27/2015 | 79ONGPOWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT | 476NO REGISTR | Division of West Coast Imports (DWCI) |
| 4/27/2015 | 79ONGPOWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT | 476NO REGISTR | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Jeisys Medical Co., Ltd.'s FDA import refusal history?
Jeisys Medical Co., Ltd. (FEI: 3006985163) has 4 FDA import refusal record(s) in our database, spanning from 4/27/2015 to 10/5/2015.
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. Jeisys Medical Co., Ltd.'s FEI number is 3006985163.
What types of violations has Jeisys Medical Co., Ltd. received?
Jeisys Medical Co., Ltd. has been cited for 4 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 Jeisys Medical Co., Ltd. come from?
All FDA import refusal data for Jeisys Medical Co., 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.