Voco GmbH
⚠️ High Risk
FEI: 3002718942 • Cuxhaven, Lower Saxony • GERMANY
FEI
FEI Number
3002718942
📍
Location
Cuxhaven, Lower Saxony
🇩🇪
Country
GERMANY🏢
Address
Anton-Flettner-Str. 1-3, , Cuxhaven, Lower Saxony, Germany
High Risk
FDA Import Risk Assessment
69.3
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
295
Total Refusals
5
Unique Violations
9/25/2025
Latest Refusal
6/25/2003
Earliest Refusal
Score Breakdown
Violation Severity
32.6×40%
Refusal Volume
91.5×30%
Recency
94.2×20%
Frequency
100.0×10%
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
341266×
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).
328028×
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.
1188×
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).
5081×
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 |
|---|---|---|---|
| 9/25/2025 | 90LLZSYSTEM, IMAGE PROCESSING | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/25/2025 | 76LBHVARNISH, CAVITY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/25/2025 | 76EMACEMENT, DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/25/2025 | 76ELWMATERIAL, IMPRESSION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/25/2025 | 76EMACEMENT, DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/25/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/25/2025 | 76EBGCROWN AND BRIDGE, TEMPORARY, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/25/2025 | 76EMACEMENT, DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/25/2025 | 76LBHVARNISH, CAVITY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/25/2025 | 76MVLCORD, RETRACTION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/25/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/25/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/25/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76EBCSEALANT, PIT AND FISSURE, AND CONDITIONER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76EMACEMENT, DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76KLEAGENT, TOOTH BONDING, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76KLEAGENT, TOOTH BONDING, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76LBHVARNISH, CAVITY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76MVLCORD, RETRACTION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76EMACEMENT, DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76EMACEMENT, DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76KLEAGENT, TOOTH BONDING, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76EBCSEALANT, PIT AND FISSURE, AND CONDITIONER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/14/2025 | 76KLEAGENT, TOOTH BONDING, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/14/2025 | 76EMACEMENT, DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/14/2025 | 76EBGCROWN AND BRIDGE, TEMPORARY, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/14/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/14/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/14/2025 | 76LBHVARNISH, CAVITY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/14/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/14/2025 | 76EMACEMENT, DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/14/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/14/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/14/2025 | 76EMACEMENT, DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/14/2025 | 76KLEAGENT, TOOTH BONDING, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/11/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/11/2025 | 76LBHVARNISH, CAVITY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/11/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/11/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/11/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/11/2025 | 76EMACEMENT, DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/11/2025 | 76LBHVARNISH, CAVITY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/11/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/18/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/18/2025 | 76EMACEMENT, DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/18/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/18/2025 | 76DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/18/2025 | 76ELWMATERIAL, IMPRESSION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/18/2025 | 76KLEAGENT, TOOTH BONDING, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/18/2025 | 76EBGCROWN AND BRIDGE, TEMPORARY, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/18/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EMACEMENT, DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBGCROWN AND BRIDGE, TEMPORARY, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76LBHVARNISH, CAVITY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EMACEMENT, DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76LBHVARNISH, CAVITY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 76EBGCROWN AND BRIDGE, TEMPORARY, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/29/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/29/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/29/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/29/2025 | 76KLEAGENT, TOOTH BONDING, RESIN | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/29/2025 | 76KLEAGENT, TOOTH BONDING, RESIN | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/29/2025 | 76LBHVARNISH, CAVITY | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/29/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/29/2025 | 76LBHVARNISH, CAVITY | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/29/2025 | 76LBHVARNISH, CAVITY | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/24/2025 | 76EBGCROWN AND BRIDGE, TEMPORARY, RESIN | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/24/2025 | 76KLEAGENT, TOOTH BONDING, RESIN | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/24/2025 | 76LBHVARNISH, CAVITY | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/24/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Voco GmbH's FDA import refusal history?
Voco GmbH (FEI: 3002718942) has 295 FDA import refusal record(s) in our database, spanning from 6/25/2003 to 9/25/2025.
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. Voco GmbH's FEI number is 3002718942.
What types of violations has Voco GmbH received?
Voco GmbH 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 Voco GmbH come from?
All FDA import refusal data for Voco 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.