Tschudin & Heid Ag
⚠️ Moderate Risk
FEI: 3005290849 • Waldenburg, Basle-Country • SWITZERLAND
FEI Number
3005290849
Location
Waldenburg, Basle-Country
Country
SWITZERLANDAddress
Haupt Strasse 35, , Waldenburg, Basle-Country, Switzerland
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/4/2013 | 79LRZSCREWDRIVER, SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/4/2013 | 79LRZSCREWDRIVER, SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/4/2013 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/4/2013 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/4/2013 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/4/2013 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/4/2013 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/4/2013 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/4/2013 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/4/2013 | 87HTJGAUGE, DEPTH | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Tschudin & Heid Ag's FDA import refusal history?
Tschudin & Heid Ag (FEI: 3005290849) has 10 FDA import refusal record(s) in our database, spanning from 1/4/2013 to 1/4/2013.
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. Tschudin & Heid Ag's FEI number is 3005290849.
What types of violations has Tschudin & Heid Ag received?
Tschudin & Heid Ag has been cited for 1 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 Tschudin & Heid Ag come from?
All FDA import refusal data for Tschudin & Heid 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.