ImportRefusal LogoImportRefusal

Medion Healthcare Pvt Ltd

⚠️ Moderate Risk

FEI: 3008459391 • Mumbai, FN • INDIA

FEI

FEI Number

3008459391

📍

Location

Mumbai, FN

🇮🇳

Country

INDIA
🏢

Address

201, Shiv Industrial Estate, , Mumbai, FN, India

Moderate Risk

FDA Import Risk Assessment

35.4
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

6
Total Refusals
2
Unique Violations
9/3/2010
Latest Refusal
9/3/2010
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

3416×

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).

5086×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
9/3/2010
73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
9/3/2010
87MOOORTHOPEDIC IMPLANT MATERIAL
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
9/3/2010
79DWGELECTROSURGICAL DEVICE
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
9/3/2010
73BSZGAS MACHINE, ANESTHESIA
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
9/3/2010
90EAJAPRON, LEADED
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
9/3/2010
90OASX-RAY, TOMOGRAPHY, COMPUTED, DENTAL
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Medion Healthcare Pvt Ltd's FDA import refusal history?

Medion Healthcare Pvt Ltd (FEI: 3008459391) has 6 FDA import refusal record(s) in our database, spanning from 9/3/2010 to 9/3/2010.

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. Medion Healthcare Pvt Ltd's FEI number is 3008459391.

What types of violations has Medion Healthcare Pvt Ltd received?

Medion Healthcare Pvt 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 Medion Healthcare Pvt Ltd come from?

All FDA import refusal data for Medion Healthcare Pvt 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.