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SHENZHEN LEAFMED TECHNOLOGY CO LIMITED

✅ Low Risk

FEI: 3017071842 • Shenzhen • CHINA

FEI

FEI Number

3017071842

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

4 F Bldg C Jmd Industrial Park No 39 Qingfeng Blvd, Baolong Industrial Area Long Gang Dist, Shenzhen, , 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
12/29/2020
Latest Refusal
12/29/2020
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
12/29/2020
83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SHENZHEN LEAFMED TECHNOLOGY CO LIMITED's FDA import refusal history?

SHENZHEN LEAFMED TECHNOLOGY CO LIMITED (FEI: 3017071842) has 1 FDA import refusal record(s) in our database, spanning from 12/29/2020 to 12/29/2020.

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 LEAFMED TECHNOLOGY CO LIMITED's FEI number is 3017071842.

What types of violations has SHENZHEN LEAFMED TECHNOLOGY CO LIMITED received?

SHENZHEN LEAFMED TECHNOLOGY CO LIMITED 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 LEAFMED TECHNOLOGY CO LIMITED come from?

All FDA import refusal data for SHENZHEN LEAFMED TECHNOLOGY CO LIMITED 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.