Thermo Fisher Scientific Nunc As
⚠️ Moderate Risk
FEI: 3008320045 • Roskilde, FN • DENMARK
FEI Number
3008320045
Location
Roskilde, FN
Country
DENMARKAddress
Kamstrupvej 90, , Roskilde, FN, Denmark
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).
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
Frequently Asked Questions
What is Thermo Fisher Scientific Nunc As's FDA import refusal history?
Thermo Fisher Scientific Nunc As (FEI: 3008320045) has 1 FDA import refusal record(s) in our database, spanning from 8/22/2025 to 8/22/2025.
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. Thermo Fisher Scientific Nunc As's FEI number is 3008320045.
What types of violations has Thermo Fisher Scientific Nunc As received?
Thermo Fisher Scientific Nunc As 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 Thermo Fisher Scientific Nunc As come from?
All FDA import refusal data for Thermo Fisher Scientific Nunc As 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.