DRG Instruments GmbH
⚠️ High Risk
FEI: 3002800697 • Marburg, Hassia • GERMANY
FEI Number
3002800697
Location
Marburg, Hassia
Country
GERMANYAddress
Frauenbergstr. 18, , Marburg, Hassia, 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
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 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).
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/22/2025 | 82DHRSYSTEM, TEST, RHEUMATOID FACTOR | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 7/9/2025 | 75JKCRADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 7/9/2025 | 82KTOREAGENT, IMMUNOASSAY, IGG | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 7/8/2025 | 83LJCENZYME LINKED IMMUNOABSORBENT ASSAY, (CHLAMYDIAE GROUP) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 7/8/2025 | 75CIZRADIOIMMUNOASSAY, ANDROSTENEDIONE | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 7/8/2025 | 75CECRADIOIMMUNOASSAY, FREE THYROXINE | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 7/8/2025 | 83MYFENZYME LINKED IMMUNOSORBENT ASSAY HERPES SIMPLEX VIRUS, HSV-2 | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 7/8/2025 | 83MYFENZYME LINKED IMMUNOSORBENT ASSAY HERPES SIMPLEX VIRUS, HSV-2 | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 7/8/2025 | 75CJMRADIOIMMUNOASSAY, ALDOSTERONE | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 7/8/2025 | 82KTOREAGENT, IMMUNOASSAY, IGG | 237NO PMA | Division of Northeast Imports (DNEI) |
| 7/8/2025 | 82KTOREAGENT, IMMUNOASSAY, IGG | 237NO PMA | Division of Northeast Imports (DNEI) |
| 7/8/2025 | 82KTOREAGENT, IMMUNOASSAY, IGG | 237NO PMA | Division of Northeast Imports (DNEI) |
| 7/8/2025 | 82KTOREAGENT, IMMUNOASSAY, IGG | 237NO PMA | Division of Northeast Imports (DNEI) |
| 7/8/2025 | 83MYLASSAY, ENZYME LINKED IMMUNOSORBENT, PARVOVIRUS B19 IGG | 237NO PMA | Division of Northeast Imports (DNEI) |
| 7/3/2025 | 83LGDENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 7/3/2025 | 83LFZENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 7/3/2025 | 83MXJENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-1 | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 7/3/2025 | 83MYFENZYME LINKED IMMUNOSORBENT ASSAY HERPES SIMPLEX VIRUS, HSV-2 | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 5/8/2025 | 75NHGENZYME IMMUNOASSAY, CORTISOL, SALIVARY | Division of Northeast Imports (DNEI) | |
| 4/16/2019 | 75NHGENZYME IMMUNOASSAY, CORTISOL, SALIVARY | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/20/2018 | 75NHGENZYME IMMUNOASSAY, CORTISOL, SALIVARY | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 12/24/2002 | 65JCJ31PROGESTERONE (PROGESTIN) | New York District Office (NYK-DO) | |
| 12/24/2002 | 61PCY17INSULIN (INJ) (ANTI-DIABETIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is DRG Instruments GmbH's FDA import refusal history?
DRG Instruments GmbH (FEI: 3002800697) has 23 FDA import refusal record(s) in our database, spanning from 12/24/2002 to 7/22/2025.
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. DRG Instruments GmbH's FEI number is 3002800697.
What types of violations has DRG Instruments GmbH received?
DRG Instruments GmbH 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 DRG Instruments GmbH come from?
All FDA import refusal data for DRG Instruments 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.