Heinen & Loewenstein Lebenserhaltende Medizintechnik
⚠️ Moderate Risk
FEI: 3002950319 • Bad Ems, Rhineland-Palatinate • GERMANY
FEI Number
3002950319
Location
Bad Ems, Rhineland-Palatinate
Country
GERMANYAddress
Arzbacher Str. 80, , Bad Ems, Rhineland-Palatinate, Germany
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/14/2014 | 73BSZGAS MACHINE, ANESTHESIA | Division of Southeast Imports (DSEI) | |
| 3/21/2013 | 73OFQANESTHESIA KIT | Florida District Office (FLA-DO) | |
| 12/26/2012 | 73OFQANESTHESIA KIT | Division of Southeast Imports (DSEI) | |
| 4/6/2012 | 73OFQANESTHESIA KIT | Division of Southeast Imports (DSEI) | |
| 4/6/2012 | 73OFQANESTHESIA KIT | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Heinen & Loewenstein Lebenserhaltende Medizintechnik's FDA import refusal history?
Heinen & Loewenstein Lebenserhaltende Medizintechnik (FEI: 3002950319) has 5 FDA import refusal record(s) in our database, spanning from 4/6/2012 to 11/14/2014.
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. Heinen & Loewenstein Lebenserhaltende Medizintechnik's FEI number is 3002950319.
What types of violations has Heinen & Loewenstein Lebenserhaltende Medizintechnik received?
Heinen & Loewenstein Lebenserhaltende Medizintechnik has been cited for 5 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 Heinen & Loewenstein Lebenserhaltende Medizintechnik come from?
All FDA import refusal data for Heinen & Loewenstein Lebenserhaltende Medizintechnik 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.