Temec Instruments B.V.
⚠️ Moderate Risk
FEI: 1000634303 • Kerkrade, Limburg • NETHERLANDS
FEI Number
1000634303
Location
Kerkrade, Limburg
Country
NETHERLANDSAddress
Spekhofstraat 2, , Kerkrade, Limburg, Netherlands
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
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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 Temec Instruments B.V.'s FDA import refusal history?
Temec Instruments B.V. (FEI: 1000634303) has 1 FDA import refusal record(s) in our database, spanning from 3/26/2003 to 3/26/2003.
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. Temec Instruments B.V.'s FEI number is 1000634303.
What types of violations has Temec Instruments B.V. received?
Temec Instruments B.V. 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 Temec Instruments B.V. come from?
All FDA import refusal data for Temec Instruments B.V. 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.