Reimers & Janssen Gmbh
⚠️ High Risk
FEI: 3008653044 • Waldkirch, Baden-wurttemberg • GERMANY
FEI Number
3008653044
Location
Waldkirch, Baden-wurttemberg
Country
GERMANYAddress
Fabrikstr. 22, , Waldkirch, Baden-wurttemberg, Germany
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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.
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).
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 TAG
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 to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/15/2024 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Northern Border Imports (DNBI) | |
| 3/15/2024 | 79LXULASER FOR WOUND HEALING | Division of Northern Border Imports (DNBI) | |
| 2/2/2024 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Northern Border Imports (DNBI) | |
| 1/30/2024 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Northern Border Imports (DNBI) | |
| 11/30/2020 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/11/2019 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | Division of Northern Border Imports (DNBI) | |
| 3/31/2017 | 84NZYLIGHT, LYMPHADEMA REDUCTION, LOW ENERGY | New Orleans District Office (NOL-DO) | |
| 3/10/2015 | 79MVFSYSTEM, LASER, PHOTODYNAMIC THERAPY | Cincinnati District Office (CIN-DO) | |
| 3/10/2015 | 79MVFSYSTEM, LASER, PHOTODYNAMIC THERAPY | Cincinnati District Office (CIN-DO) | |
| 3/10/2015 | 79MVFSYSTEM, LASER, PHOTODYNAMIC THERAPY | Cincinnati District Office (CIN-DO) | |
| 3/7/2014 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 508NO 510(K) | New York District Office (NYK-DO) |
| 1/21/2014 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | New Orleans District Office (NOL-DO) | |
| 1/17/2014 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | New Orleans District Office (NOL-DO) | |
| 1/17/2014 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | New Orleans District Office (NOL-DO) | |
| 1/17/2014 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | New Orleans District Office (NOL-DO) | |
| 1/17/2014 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | New Orleans District Office (NOL-DO) | |
| 1/17/2014 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | New Orleans District Office (NOL-DO) | |
| 1/17/2014 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | New Orleans District Office (NOL-DO) | |
| 11/20/2013 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 3/25/2013 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Reimers & Janssen Gmbh's FDA import refusal history?
Reimers & Janssen Gmbh (FEI: 3008653044) has 20 FDA import refusal record(s) in our database, spanning from 3/25/2013 to 3/15/2024.
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's FEI number is 3008653044.
What types of violations has Reimers & Janssen Gmbh received?
Reimers & Janssen Gmbh has been cited for 8 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 come from?
All FDA import refusal data for Reimers & Janssen Gmbh 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.