ImportRefusal LogoImportRefusal

Hangzhou Suning Medical Co., Ltd.

✅ Low Risk

FEI: 3012454004 • Hangzhou, Zhejiang • CHINA

FEI

FEI Number

3012454004

📍

Location

Hangzhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Room 625, 23 Youdian Road; Shangcheng District, Hangzhou, Zhejiang, China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
11/13/2018
Latest Refusal
11/13/2018
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

1181×

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).

Refusal History

DateProductViolationsDivision
11/13/2018
80FQMBANDAGE, ELASTIC
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Hangzhou Suning Medical Co., Ltd.'s FDA import refusal history?

Hangzhou Suning Medical Co., Ltd. (FEI: 3012454004) has 1 FDA import refusal record(s) in our database, spanning from 11/13/2018 to 11/13/2018.

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 Suning Medical Co., Ltd.'s FEI number is 3012454004.

What types of violations has Hangzhou Suning Medical Co., Ltd. received?

Hangzhou Suning Medical Co., Ltd. has been cited for 1 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 Suning Medical Co., Ltd. come from?

All FDA import refusal data for Hangzhou Suning Medical 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.