Hangzhou Hua'an Medical & Health Instruments Co., Ltd.
⚠️ Moderate Risk
FEI: 3003981912 • Hangzhou, Zhejiang • CHINA
FEI Number
3003981912
Location
Hangzhou, Zhejiang
Country
CHINAAddress
Bldg 2 Baimiao Ind. Park, Economic Development Zone,Wuchang, Hangzhou, Zhejiang, 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/11/2024 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 8/30/2017 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | Division of Southeast Imports (DSEI) | |
| 8/28/2017 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | Division of Southeast Imports (DSEI) | |
| 12/31/2015 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 333LACKS FIRM | New Orleans District Office (NOL-DO) |
| 12/14/2015 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 333LACKS FIRM | New Orleans District Office (NOL-DO) |
| 9/23/2015 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | New Orleans District Office (NOL-DO) | |
| 4/23/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/5/2008 | 74DSKCOMPUTER, BLOOD-PRESSURE | Seattle District Office (SEA-DO) | |
| 4/7/2005 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 341REGISTERED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Hangzhou Hua'an Medical & Health Instruments Co., Ltd.'s FDA import refusal history?
Hangzhou Hua'an Medical & Health Instruments Co., Ltd. (FEI: 3003981912) has 9 FDA import refusal record(s) in our database, spanning from 4/7/2005 to 10/11/2024.
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. Hangzhou Hua'an Medical & Health Instruments Co., Ltd.'s FEI number is 3003981912.
What types of violations has Hangzhou Hua'an Medical & Health Instruments Co., Ltd. received?
Hangzhou Hua'an Medical & Health Instruments Co., Ltd. has been cited for 7 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 Hangzhou Hua'an Medical & Health Instruments Co., Ltd. come from?
All FDA import refusal data for Hangzhou Hua'an Medical & Health Instruments 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.