Tytan Medical Corp. Shanghai
⚠️ Moderate Risk
FEI: 3003483105 • Shanghai, Shanghai • CHINA
FEI Number
3003483105
Location
Shanghai, Shanghai
Country
CHINAAddress
No. 785 Chengfenglu, Pudongxin, Shanghai, 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
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.
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.
Refusal History
Frequently Asked Questions
What is Tytan Medical Corp. Shanghai's FDA import refusal history?
Tytan Medical Corp. Shanghai (FEI: 3003483105) has 1 FDA import refusal record(s) in our database, spanning from 11/12/2010 to 11/12/2010.
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. Tytan Medical Corp. Shanghai's FEI number is 3003483105.
What types of violations has Tytan Medical Corp. Shanghai received?
Tytan Medical Corp. Shanghai has been cited for 2 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 Tytan Medical Corp. Shanghai come from?
All FDA import refusal data for Tytan Medical Corp. Shanghai 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.