SWISS BIONIC SOLUTIONS SCHWEIZ
⚠️ High Risk
FEI: 3025362429 • Reichenburg • SWITZERLAND
FEI Number
3025362429
Location
Reichenburg
Country
SWITZERLANDAddress
Gewerbecenter Glaentern1,3 5, , Reichenburg, , Switzerland
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/24/2025 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 237NO PMA | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is SWISS BIONIC SOLUTIONS SCHWEIZ's FDA import refusal history?
SWISS BIONIC SOLUTIONS SCHWEIZ (FEI: 3025362429) has 1 FDA import refusal record(s) in our database, spanning from 7/24/2025 to 7/24/2025.
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. SWISS BIONIC SOLUTIONS SCHWEIZ's FEI number is 3025362429.
What types of violations has SWISS BIONIC SOLUTIONS SCHWEIZ received?
SWISS BIONIC SOLUTIONS SCHWEIZ 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 SWISS BIONIC SOLUTIONS SCHWEIZ come from?
All FDA import refusal data for SWISS BIONIC SOLUTIONS SCHWEIZ 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.