Ching Ming Medical Device Co., Ltd.
⚠️ Moderate Risk
FEI: 3014642341 • New Taipei City • TAIWAN
FEI Number
3014642341
Location
New Taipei City
Country
TAIWANAddress
5f-6, Wugu Dist, New Taipei City, , Taiwan
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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
STERILITY
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance.
NO TAG
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
STD LABEL
The article appears to not bear labeling prescribed by the performance standard established under section 514.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/19/2020 | 89KNMDEVICE, PRESSURE APPLYING | Division of West Coast Imports (DWCI) | |
| 2/19/2020 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | Division of West Coast Imports (DWCI) | |
| 2/19/2020 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | Division of West Coast Imports (DWCI) | |
| 2/19/2020 | 89KNMDEVICE, PRESSURE APPLYING | Division of West Coast Imports (DWCI) | |
| 2/19/2020 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | Division of West Coast Imports (DWCI) | |
| 2/19/2020 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Ching Ming Medical Device Co., Ltd.'s FDA import refusal history?
Ching Ming Medical Device Co., Ltd. (FEI: 3014642341) has 6 FDA import refusal record(s) in our database, spanning from 2/19/2020 to 2/19/2020.
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. Ching Ming Medical Device Co., Ltd.'s FEI number is 3014642341.
What types of violations has Ching Ming Medical Device Co., Ltd. received?
Ching Ming Medical Device Co., Ltd. has been cited for 5 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 Ching Ming Medical Device Co., Ltd. come from?
All FDA import refusal data for Ching Ming Medical Device 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.