NIDEK Co., Ltd.
⚠️ Moderate Risk
FEI: 3002807715 • Gamagoori, Aichi • JAPAN
FEI Number
3002807715
Location
Gamagoori, Aichi
Country
JAPANAddress
34-14, Hiroishi-Cho, Gamagoori, Aichi, Japan
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
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).
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).
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.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/20/2017 | 86HQFLASER, OPHTHALMIC | 126FAILS STD | Division of Southeast Imports (DSEI) |
| 8/18/2015 | 86LZSLASER, SYSTEM, EXCIMER | 2380NO PMA/PDP | Cincinnati District Office (CIN-DO) |
| 4/3/2015 | 86HJLLENS, CONDENSING, DIAGNOSTIC | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/10/2013 | 86MYCOPHTHALMOSCOPE, LASER, SCANNING | 341REGISTERED | Florida District Office (FLA-DO) |
| 9/13/2010 | 86HQRAPPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED | Division of Southeast Imports (DSEI) | |
| 5/14/2008 | 86LZSLASER, SYSTEM, EXCIMER | 237NO PMA | Florida District Office (FLA-DO) |
| 1/29/2004 | 80LDQDEVICE, GENERAL MEDICAL | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is NIDEK Co., Ltd.'s FDA import refusal history?
NIDEK Co., Ltd. (FEI: 3002807715) has 7 FDA import refusal record(s) in our database, spanning from 1/29/2004 to 6/20/2017.
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. NIDEK Co., Ltd.'s FEI number is 3002807715.
What types of violations has NIDEK Co., Ltd. received?
NIDEK Co., Ltd. has been cited for 6 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 NIDEK Co., Ltd. come from?
All FDA import refusal data for NIDEK 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.