Mezorrison Health Science & Technology (Shenzhen) Co.,Ltd
⚠️ Moderate Risk
FEI: 3016733880 • Shenzhen, Guangdong • CHINA
FEI Number
3016733880
Location
Shenzhen, Guangdong
Country
CHINAAddress
12 Yuhe Road, Bao'An District Shiyan Town, Shenzhen, Guangdong, China
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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
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 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.
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
NONSTEEL
Labeling appears false or misleading or fails to bear adequate directions for use,because the article appears to be misrepresented as a disposable single use instrument when it is intended for use as a stainless steel multi-use instrument.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/9/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 8/17/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 7/28/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 7/28/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 7/28/2020 | 80MSHRESPIRATOR, SURGICAL | Division of Southeast Imports (DSEI) | |
| 7/28/2020 | 80FXXMASK, SURGICAL | Division of Southeast Imports (DSEI) | |
| 7/28/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Mezorrison Health Science & Technology (Shenzhen) Co.,Ltd's FDA import refusal history?
Mezorrison Health Science & Technology (Shenzhen) Co.,Ltd (FEI: 3016733880) has 7 FDA import refusal record(s) in our database, spanning from 7/28/2020 to 9/9/2020.
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. Mezorrison Health Science & Technology (Shenzhen) Co.,Ltd's FEI number is 3016733880.
What types of violations has Mezorrison Health Science & Technology (Shenzhen) Co.,Ltd received?
Mezorrison Health Science & Technology (Shenzhen) Co.,Ltd has been cited for 10 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 Mezorrison Health Science & Technology (Shenzhen) Co.,Ltd come from?
All FDA import refusal data for Mezorrison Health Science & Technology (Shenzhen) 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.