Nidacon International
⚠️ Moderate Risk
FEI: 3004848623 • Molndal, Vastra Gotalands Lan • SWEDEN
FEI Number
3004848623
Location
Molndal, Vastra Gotalands Lan
Country
SWEDENAddress
Flojelbergsgatan 16 B, , Molndal, Vastra Gotalands Lan, Sweden
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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/16/2025 | 85MQLMEDIA, REPRODUCTIVE | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 9/16/2025 | 85MQLMEDIA, REPRODUCTIVE | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 9/16/2025 | 85MQLMEDIA, REPRODUCTIVE | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 9/16/2025 | 85MQLMEDIA, REPRODUCTIVE | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 9/16/2025 | 85MQLMEDIA, REPRODUCTIVE | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 10/24/2024 | 85MQLMEDIA, REPRODUCTIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/24/2024 | 85MQLMEDIA, REPRODUCTIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/24/2024 | 85MQLMEDIA, REPRODUCTIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/24/2024 | 85MQLMEDIA, REPRODUCTIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/3/2024 | 85MQLMEDIA, REPRODUCTIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/3/2024 | 85MQLMEDIA, REPRODUCTIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/3/2024 | 85MQLMEDIA, REPRODUCTIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/3/2024 | 85MQLMEDIA, REPRODUCTIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/3/2024 | 85MQLMEDIA, REPRODUCTIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/3/2024 | 85MQLMEDIA, REPRODUCTIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/5/2021 | 85MQLMEDIA, REPRODUCTIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Nidacon International's FDA import refusal history?
Nidacon International (FEI: 3004848623) has 16 FDA import refusal record(s) in our database, spanning from 3/5/2021 to 9/16/2025.
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. Nidacon International's FEI number is 3004848623.
What types of violations has Nidacon International received?
Nidacon International 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 Nidacon International come from?
All FDA import refusal data for Nidacon International 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.