Diagnoptics Technologies B.V.

⚠️ Moderate Risk

FEI: 3010309834 • Groningen, Groningen • NETHERLANDS

FEI

FEI Number

3010309834

📍

Location

Groningen, Groningen

🇳🇱

Country

NETHERLANDS

🏢

Address

L.J. Zielstraweg 1, , Groningen, Groningen, Netherlands

Moderate Risk

FDA Import Risk Assessment

47.9

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

8/29/2013

Latest Refusal

4/26/2013

Earliest Refusal

Score Breakdown

Violation Severity

50.1×40%

Refusal Volume

59.3×30%

Recency

0.0×20%

Frequency

100.0×10%

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

11839×

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).

50839×

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.

34138×

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).

328036×

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.

Refusal History

Date	Product	Violations	Division
8/29/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/19/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/13/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
8/7/2013	74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
4/26/2013	74KRCTESTER, ELECTRODE, SURFACE, ELECTROCARDIOGRAPHIC	118NOT LISTED 508NO 510(K)	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Diagnoptics Technologies B.V.'s FDA import refusal history?

Diagnoptics Technologies B.V. (FEI: 3010309834) has 39 FDA import refusal record(s) in our database, spanning from 4/26/2013 to 8/29/2013.

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. Diagnoptics Technologies B.V.'s FEI number is 3010309834.

What types of violations has Diagnoptics Technologies B.V. received?

Diagnoptics Technologies B.V. 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 Diagnoptics Technologies B.V. come from?

All FDA import refusal data for Diagnoptics Technologies B.V. 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.