CARL ZEISS CMP GMBH
⚠️ Moderate Risk
FEI: 3005060446 • Gottingen, Lower Saxony • GERMANY
FEI Number
3005060446
Location
Gottingen, Lower Saxony
Country
GERMANYAddress
Konigsallee 9-21, , Gottingen, Lower Saxony, 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 REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/15/2016 | 95REILASER SCIENCE EDUCATION PRODUCTS | 476NO REGISTR | New York District Office (NYK-DO) |
| 12/15/2016 | 95REILASER SCIENCE EDUCATION PRODUCTS | 476NO REGISTR | New York District Office (NYK-DO) |
| 12/15/2016 | 95REILASER SCIENCE EDUCATION PRODUCTS | 476NO REGISTR | New York District Office (NYK-DO) |
| 10/22/2003 | 95U28MERCURY VAPOR LAMP FOR NON-MEDICAL USE | 476NO REGISTR | New York District Office (NYK-DO) |
| 3/18/2002 | 90IXACASSETTE, RADIOGRAPHIC FILM | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is CARL ZEISS CMP GMBH's FDA import refusal history?
CARL ZEISS CMP GMBH (FEI: 3005060446) has 5 FDA import refusal record(s) in our database, spanning from 3/18/2002 to 12/15/2016.
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. CARL ZEISS CMP GMBH's FEI number is 3005060446.
What types of violations has CARL ZEISS CMP GMBH received?
CARL ZEISS CMP GMBH 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 CARL ZEISS CMP GMBH come from?
All FDA import refusal data for CARL ZEISS CMP 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.