Jianda Medical Apparatus & Instruments Co., Ltd.
⚠️ Moderate Risk
FEI: 3003802366 • Shanghai • CHINA
FEI Number
3003802366
Location
Shanghai
Country
CHINAAddress
700 Laohuming Road, , Shanghai, , 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
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.
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).
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/17/2006 | 78EYNTRAY, IRRIGATION, STERILE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/6/2004 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southeast Imports (DSEI) |
| 12/6/2004 | 79EFQSPONGE, GAUZE | Division of Southeast Imports (DSEI) | |
| 12/6/2004 | 73EPEBRUSH, CLEANING, TRACHEAL TUBE | Division of Southeast Imports (DSEI) | |
| 12/6/2004 | 85HIBSPECULUM, VAGINAL, NONMETAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Jianda Medical Apparatus & Instruments Co., Ltd.'s FDA import refusal history?
Jianda Medical Apparatus & Instruments Co., Ltd. (FEI: 3003802366) has 5 FDA import refusal record(s) in our database, spanning from 12/6/2004 to 7/17/2006.
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. Jianda Medical Apparatus & Instruments Co., Ltd.'s FEI number is 3003802366.
What types of violations has Jianda Medical Apparatus & Instruments Co., Ltd. received?
Jianda Medical Apparatus & Instruments Co., Ltd. has been cited for 3 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 Jianda Medical Apparatus & Instruments Co., Ltd. come from?
All FDA import refusal data for Jianda Medical Apparatus & 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.