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SHENZHEN DENCO MEDICAL CO., LTD.

✅ Low Risk

FEI: 3011554142 • Shenzhen, Guangdong • CHINA

FEI

FEI Number

3011554142

📍

Location

Shenzhen, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Meicheng Technology Park 6th Floor, Gongminglu; Baoan, Shenzhen, Guangdong, China

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/2/2020
Latest Refusal
3/2/2020
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

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
3/2/2020
76EKSFILE, PULP CANAL, ENDODONTIC
341REGISTERED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is SHENZHEN DENCO MEDICAL CO., LTD.'s FDA import refusal history?

SHENZHEN DENCO MEDICAL CO., LTD. (FEI: 3011554142) has 1 FDA import refusal record(s) in our database, spanning from 3/2/2020 to 3/2/2020.

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. SHENZHEN DENCO MEDICAL CO., LTD.'s FEI number is 3011554142.

What types of violations has SHENZHEN DENCO MEDICAL CO., LTD. received?

SHENZHEN DENCO 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 SHENZHEN DENCO MEDICAL CO., LTD. come from?

All FDA import refusal data for SHENZHEN DENCO 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.