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Shenzhen Perfect Idea Technology Co., Ltd.

✅ Low Risk

FEI: 3013608307 • Shenzhen, Guangdong • CHINA

FEI

FEI Number

3013608307

📍

Location

Shenzhen, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Building 1 F 4, Fuyong Street; Baoan District, Shenzhen, Guangdong, China

Low Risk

FDA Import Risk Assessment

23.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
12/5/2019
Latest Refusal
12/5/2019
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1182×

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).

3412×

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
12/5/2019
89ILYLAMP, INFRARED, THERAPEUTIC HEATING
118NOT LISTED
341REGISTERED
Division of West Coast Imports (DWCI)
12/5/2019
89ILYLAMP, INFRARED, THERAPEUTIC HEATING
118NOT LISTED
341REGISTERED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Shenzhen Perfect Idea Technology Co., Ltd.'s FDA import refusal history?

Shenzhen Perfect Idea Technology Co., Ltd. (FEI: 3013608307) has 2 FDA import refusal record(s) in our database, spanning from 12/5/2019 to 12/5/2019.

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 Perfect Idea Technology Co., Ltd.'s FEI number is 3013608307.

What types of violations has Shenzhen Perfect Idea Technology Co., Ltd. received?

Shenzhen Perfect Idea Technology Co., 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 Shenzhen Perfect Idea Technology Co., Ltd. come from?

All FDA import refusal data for Shenzhen Perfect Idea Technology 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.