Linde Ag
⚠️ Moderate Risk
FEI: 3002728090 • Unterschleisheim, Bavaria • GERMANY
FEI Number
3002728090
Location
Unterschleisheim, Bavaria
Country
GERMANYAddress
Carl-von-Linde-Str. 25, , Unterschleisheim, Bavaria, 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
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 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).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/7/2002 | 86LPOGASES USED WITHIN EYE TO PLACE PRESSURE ON DETACHED RETINA | Florida District Office (FLA-DO) | |
| 11/7/2002 | 86LPOGASES USED WITHIN EYE TO PLACE PRESSURE ON DETACHED RETINA | Florida District Office (FLA-DO) | |
| 11/7/2002 | 86LPOGASES USED WITHIN EYE TO PLACE PRESSURE ON DETACHED RETINA | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Linde Ag's FDA import refusal history?
Linde Ag (FEI: 3002728090) has 3 FDA import refusal record(s) in our database, spanning from 11/7/2002 to 11/7/2002.
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. Linde Ag's FEI number is 3002728090.
What types of violations has Linde Ag received?
Linde Ag 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 Linde Ag come from?
All FDA import refusal data for Linde Ag 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.