Siemens Healthcare Diagnostics Products Ltd.
⚠️ Moderate Risk
FEI: 3002806944 • Caernarfon • UNITED KINGDOM
FEI Number
3002806944
Location
Caernarfon
Country
UNITED KINGDOMAddress
Glyn Rhonwy, , Caernarfon, , United Kingdom
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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).
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.
Refusal History
Frequently Asked Questions
What is Siemens Healthcare Diagnostics Products Ltd.'s FDA import refusal history?
Siemens Healthcare Diagnostics Products Ltd. (FEI: 3002806944) has 2 FDA import refusal record(s) in our database, spanning from 1/12/2011 to 10/19/2011.
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. Siemens Healthcare Diagnostics Products Ltd.'s FEI number is 3002806944.
What types of violations has Siemens Healthcare Diagnostics Products Ltd. received?
Siemens Healthcare Diagnostics Products Ltd. has been cited for 4 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 Siemens Healthcare Diagnostics Products Ltd. come from?
All FDA import refusal data for Siemens Healthcare Diagnostics Products Ltd. 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.