ImportRefusal LogoImportRefusal

Mar Flow Ag

⚠️ Moderate Risk

FEI: 3005621225 • Adliswil, Zurich • SWITZERLAND

FEI

FEI Number

3005621225

📍

Location

Adliswil, Zurich

🇨🇭
🏢

Address

Soodstrasse 57, , Adliswil, Zurich, Switzerland

Moderate Risk

FDA Import Risk Assessment

34.4
LowModerateHighCritical

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

Statistics

8
Total Refusals
2
Unique Violations
6/2/2008
Latest Refusal
4/18/2006
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
37.6×10%
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

3418×

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).

5088×

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
6/2/2008
79GCBNEEDLE, CATHETER
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
6/2/2008
79GCCDILATOR, CATHETER
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
6/2/2008
79GENFORCEPS, GENERAL & PLASTIC SURGERY
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
6/2/2008
74OFBCATHETER GUIDE WIRE KIT
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
6/2/2008
79GBOCATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
6/2/2008
74MAFSTENT, CARDIOVASCULAR
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
4/18/2006
78LJHSYSTEM, IRRIGATION, UROLOGICAL
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
4/18/2006
78LJHSYSTEM, IRRIGATION, UROLOGICAL
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Mar Flow Ag's FDA import refusal history?

Mar Flow Ag (FEI: 3005621225) has 8 FDA import refusal record(s) in our database, spanning from 4/18/2006 to 6/2/2008.

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. Mar Flow Ag's FEI number is 3005621225.

What types of violations has Mar Flow Ag received?

Mar Flow Ag 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 Mar Flow Ag come from?

All FDA import refusal data for Mar Flow Ag 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.