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Medstar Medical Int'l (Shanghai) Co., Ltd.

✅ Low Risk

FEI: 3005695733 • Shanghai • CHINA

FEI

FEI Number

3005695733

📍

Location

Shanghai

🇨🇳

Country

CHINA
🏢

Address

Rm. 1123, Cimic Tower, 1090 Century Blvd., Shanghai, , 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
10/17/2017
Latest Refusal
10/17/2017
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
10/17/2017
74DXQCUFF, BLOOD-PRESSURE
118NOT LISTED
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Medstar Medical Int'l (Shanghai) Co., Ltd.'s FDA import refusal history?

Medstar Medical Int'l (Shanghai) Co., Ltd. (FEI: 3005695733) has 1 FDA import refusal record(s) in our database, spanning from 10/17/2017 to 10/17/2017.

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. Medstar Medical Int'l (Shanghai) Co., Ltd.'s FEI number is 3005695733.

What types of violations has Medstar Medical Int'l (Shanghai) Co., Ltd. received?

Medstar Medical Int'l (Shanghai) 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 Medstar Medical Int'l (Shanghai) Co., Ltd. come from?

All FDA import refusal data for Medstar Medical Int'l (Shanghai) 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.