Carl Zeiss Meditec AG

⚠️ Moderate Risk

FEI: 3003481798 • Oberkochen, Baden-Wurttemberg • GERMANY

FEI

FEI Number

3003481798

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Location

Oberkochen, Baden-Wurttemberg

🇩🇪

Country

GERMANY

🏢

Address

Rudolf-Eber-Str. 11, , Oberkochen, Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

28.6

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

6/5/2017

Latest Refusal

11/9/2001

Earliest Refusal

Score Breakdown

Violation Severity

54.3×40%

Refusal Volume

22.3×30%

Recency

0.0×20%

Frequency

1.9×10%

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

Violation Summary

1182×

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).

3412×

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).

5082×

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.

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

Date	Product	Violations	Division
6/5/2017	86HJOBIOMICROSCOPE, SLIT-LAMP, AC-POWERED	341REGISTERED	Division of Southeast Imports (DSEI)
10/20/2015	86LZSLASER, SYSTEM, EXCIMER	118NOT LISTED 126FAILS STD 508NO 510(K)	Division of Southeast Imports (DSEI)
11/9/2001	86HJOBIOMICROSCOPE, SLIT-LAMP, AC-POWERED	118NOT LISTED 341REGISTERED 508NO 510(K)	San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Carl Zeiss Meditec AG's FDA import refusal history?

Carl Zeiss Meditec AG (FEI: 3003481798) has 3 FDA import refusal record(s) in our database, spanning from 11/9/2001 to 6/5/2017.

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 Meditec AG's FEI number is 3003481798.

What types of violations has Carl Zeiss Meditec AG received?

Carl Zeiss Meditec AG has been cited for 4 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 Meditec AG come from?

All FDA import refusal data for Carl Zeiss Meditec 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.