Instrumed GmbH dba Avalign German Specialty Instruments
⚠️ Moderate Risk
FEI: 3007290840 • Tuttlingen, Baden-Wurttemberg • GERMANY
FEI Number
3007290840
Location
Tuttlingen, Baden-Wurttemberg
Country
GERMANYAddress
Unter Buchsteig 3, , Tuttlingen, 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
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.
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).
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
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.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/25/2025 | 85HDFSPECULUM, VAGINAL, METAL | 290DE IMP GMP | Division of Northern Border Imports (DNBI) |
| 4/25/2025 | 79FZTCUTTER, SURGICAL | 290DE IMP GMP | Division of Northern Border Imports (DNBI) |
| 9/30/2022 | 74DWPDILATOR, VESSEL, SURGICAL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 1/14/2022 | 74DWPDILATOR, VESSEL, SURGICAL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 3/27/2018 | 84HBGDRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL) | Division of Southeast Imports (DSEI) | |
| 2/6/2018 | 74DWPDILATOR, VESSEL, SURGICAL | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Instrumed GmbH dba Avalign German Specialty Instruments's FDA import refusal history?
Instrumed GmbH dba Avalign German Specialty Instruments (FEI: 3007290840) has 6 FDA import refusal record(s) in our database, spanning from 2/6/2018 to 4/25/2025.
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. Instrumed GmbH dba Avalign German Specialty Instruments's FEI number is 3007290840.
What types of violations has Instrumed GmbH dba Avalign German Specialty Instruments received?
Instrumed GmbH dba Avalign German Specialty Instruments 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 Instrumed GmbH dba Avalign German Specialty Instruments come from?
All FDA import refusal data for Instrumed GmbH dba Avalign German Specialty Instruments 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.