NINGBO HAISHENG MEDICAL TECHNOLO
⚠️ Moderate Risk
FEI: 3027512263 • Ningbo City • CHINA
FEI Number
3027512263
Location
Ningbo City
Country
CHINAAddress
Add 7-05 Washou Rd, , Ningbo City, , 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
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).
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).
Refusal History
Frequently Asked Questions
What is NINGBO HAISHENG MEDICAL TECHNOLO's FDA import refusal history?
NINGBO HAISHENG MEDICAL TECHNOLO (FEI: 3027512263) has 1 FDA import refusal record(s) in our database, spanning from 8/16/2023 to 8/16/2023.
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. NINGBO HAISHENG MEDICAL TECHNOLO's FEI number is 3027512263.
What types of violations has NINGBO HAISHENG MEDICAL TECHNOLO received?
NINGBO HAISHENG MEDICAL TECHNOLO 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 NINGBO HAISHENG MEDICAL TECHNOLO come from?
All FDA import refusal data for NINGBO HAISHENG MEDICAL TECHNOLO 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.