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Ruetschi Technology Ag

⚠️ Moderate Risk

FEI: 3005827567 • Muntelier, Fribourg • SWITZERLAND

FEI

FEI Number

3005827567

📍

Location

Muntelier, Fribourg

🇨🇭
🏢

Address

Fabrikstrasse 35, , Muntelier, Fribourg, Switzerland

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

11
Total Refusals
2
Unique Violations
8/23/2011
Latest Refusal
2/21/2006
Earliest Refusal

Score Breakdown

Violation Severity
65.7×40%
Refusal Volume
40.0×30%
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

50811×

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.

1183×

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).

Refusal History

DateProductViolationsDivision
8/23/2011
77LMRIMPLANT, COCHLEAR
508NO 510(K)
New England District Office (NWE-DO)
8/23/2011
77LMRIMPLANT, COCHLEAR
508NO 510(K)
New England District Office (NWE-DO)
8/23/2011
79KDCINSTRUMENT, SURGICAL, DISPOSABLE
508NO 510(K)
New England District Office (NWE-DO)
8/23/2011
79KDCINSTRUMENT, SURGICAL, DISPOSABLE
508NO 510(K)
New England District Office (NWE-DO)
8/23/2011
77MAHHEARING-AID, BONE-CONDUCTION, IMPLANTED
508NO 510(K)
New England District Office (NWE-DO)
2/25/2011
77LMRIMPLANT, COCHLEAR
508NO 510(K)
New England District Office (NWE-DO)
1/4/2011
79KDCINSTRUMENT, SURGICAL, DISPOSABLE
508NO 510(K)
New England District Office (NWE-DO)
1/4/2011
79KDCINSTRUMENT, SURGICAL, DISPOSABLE
508NO 510(K)
New England District Office (NWE-DO)
6/1/2006
76JEYPLATE, BONE
118NOT LISTED
508NO 510(K)
Cincinnati District Office (CIN-DO)
2/21/2006
76DZEIMPLANT, ENDOSSEOUS
118NOT LISTED
508NO 510(K)
New York District Office (NYK-DO)
2/21/2006
76DZEIMPLANT, ENDOSSEOUS
118NOT LISTED
508NO 510(K)
New York District Office (NYK-DO)

Frequently Asked Questions

What is Ruetschi Technology Ag's FDA import refusal history?

Ruetschi Technology Ag (FEI: 3005827567) has 11 FDA import refusal record(s) in our database, spanning from 2/21/2006 to 8/23/2011.

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. Ruetschi Technology Ag's FEI number is 3005827567.

What types of violations has Ruetschi Technology Ag received?

Ruetschi Technology 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 Ruetschi Technology Ag come from?

All FDA import refusal data for Ruetschi Technology 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.