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GN Resound China, Ltd.

✅ Low Risk

FEI: 3003303986 • Xiamen, Fujian • CHINA

FEI

FEI Number

3003303986

📍

Location

Xiamen, Fujian

🇨🇳

Country

CHINA
🏢

Address

15 Chuang Xin Road, Huli District, Xiamen, Fujian, China

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
7/27/2021
Latest Refusal
7/27/2021
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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).

3411×

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

DateProductViolationsDivision
7/27/2021
77OSMHEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY
118NOT LISTED
341REGISTERED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is GN Resound China, Ltd.'s FDA import refusal history?

GN Resound China, Ltd. (FEI: 3003303986) has 1 FDA import refusal record(s) in our database, spanning from 7/27/2021 to 7/27/2021.

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. GN Resound China, Ltd.'s FEI number is 3003303986.

What types of violations has GN Resound China, Ltd. received?

GN Resound China, Ltd. 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 GN Resound China, Ltd. come from?

All FDA import refusal data for GN Resound China, 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.