Reimers & Janssen GmbH Medizintechnik
⚠️ Moderate Risk
FEI: 3002850396 • Winden im Elztal, Baden-Wurttemberg • GERMANY
FEI Number
3002850396
Location
Winden im Elztal, Baden-Wurttemberg
Country
GERMANYAddress
Kirchberg 1A, , Winden im Elztal, Baden-Wurttemberg, 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).
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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
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 |
|---|---|---|---|
| 10/30/2015 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | Cincinnati District Office (CIN-DO) | |
| 3/13/2008 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 126FAILS STD | New Orleans District Office (NOL-DO) |
| 7/10/2007 | 95RGBVETERINARY LASER, IN VITRO AND OTHER MEDICAL LASER PRODUCTS | 126FAILS STD | New Orleans District Office (NOL-DO) |
| 5/10/2007 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | New Orleans District Office (NOL-DO) | |
| 11/17/2006 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 126FAILS STD | New Orleans District Office (NOL-DO) |
| 10/15/2001 | 76EJBHANDLE, INSTRUMENT, DENTAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/15/2001 | 76EKZUNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Reimers & Janssen GmbH Medizintechnik's FDA import refusal history?
Reimers & Janssen GmbH Medizintechnik (FEI: 3002850396) has 7 FDA import refusal record(s) in our database, spanning from 10/15/2001 to 10/30/2015.
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. Reimers & Janssen GmbH Medizintechnik's FEI number is 3002850396.
What types of violations has Reimers & Janssen GmbH Medizintechnik received?
Reimers & Janssen GmbH Medizintechnik has been cited for 6 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 Reimers & Janssen GmbH Medizintechnik come from?
All FDA import refusal data for Reimers & Janssen GmbH 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.