GE HEALTHCARE AUSTRIA GMBH & CO OG
⚠️ Moderate Risk
FEI: 3004377820 • Pfaffing, Upper Austria • AUSTRIA
FEI Number
3004377820
Location
Pfaffing, Upper Austria
Country
AUSTRIAAddress
Tiefenbach 15, , Pfaffing, Upper Austria, Austria
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
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/28/2023 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/28/2023 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/24/2019 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 8/7/2006 | 74MLOELECTROCARDIOGRAPH, AMBULATORY WITH ANALYSIS ALGORITHM | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/8/2006 | 97U09ULTRASOUND PRODUCT FOR NON-MEDICAL USE | Florida District Office (FLA-DO) | |
| 3/31/2004 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 3/31/2004 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is GE HEALTHCARE AUSTRIA GMBH & CO OG's FDA import refusal history?
GE HEALTHCARE AUSTRIA GMBH & CO OG (FEI: 3004377820) has 7 FDA import refusal record(s) in our database, spanning from 3/31/2004 to 3/28/2023.
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. GE HEALTHCARE AUSTRIA GMBH & CO OG's FEI number is 3004377820.
What types of violations has GE HEALTHCARE AUSTRIA GMBH & CO OG received?
GE HEALTHCARE AUSTRIA GMBH & CO OG has been cited for 3 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 GE HEALTHCARE AUSTRIA GMBH & CO OG come from?
All FDA import refusal data for GE HEALTHCARE AUSTRIA GMBH & CO OG 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.