GE Healthcare Finland Oy

⚠️ Moderate Risk

FEI: 3002806783 • Helsinki, Uusimaa • FINLAND

FEI

FEI Number

3002806783

📍

Location

Helsinki, Uusimaa

🇫🇮

Country

FINLAND

🏢

Address

Kuortaneenkatu 2, , Helsinki, Uusimaa, Finland

Moderate Risk

FDA Import Risk Assessment

48.8

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

1/19/2023

Latest Refusal

6/1/2005

Earliest Refusal

Score Breakdown

Violation Severity

51.7×40%

Refusal Volume

59.3×30%

Recency

40.4×20%

Frequency

22.1×10%

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

50823×

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.

34120×

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).

11810×

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).

32803×

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.

472×

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
1/19/2023	74MHXMONITOR, PHYSIOLOGICAL, PATIENT	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
3/23/2022	73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	3280FRNMFGREG	Division of Southwest Imports (DSWI)
3/3/2021	73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	118NOT LISTED 508NO 510(K)	Division of Northern Border Imports (DNBI)
3/3/2021	73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	118NOT LISTED 508NO 510(K)	Division of Northern Border Imports (DNBI)
3/3/2021	73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	118NOT LISTED 508NO 510(K)	Division of Northern Border Imports (DNBI)
3/3/2021	73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	118NOT LISTED 508NO 510(K)	Division of Northern Border Imports (DNBI)
3/3/2021	73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	118NOT LISTED 508NO 510(K)	Division of Northern Border Imports (DNBI)
3/3/2021	73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	118NOT LISTED 508NO 510(K)	Division of Northern Border Imports (DNBI)
3/3/2021	73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	118NOT LISTED 508NO 510(K)	Division of Northern Border Imports (DNBI)
9/8/2020	73CCLANALYZER, GAS, OXYGEN, GASEOUS-PHASE	341REGISTERED	Division of Southeast Imports (DSEI)
12/6/2019	73CCLANALYZER, GAS, OXYGEN, GASEOUS-PHASE	3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
12/29/2016	73BYXTUBING, PRESSURE AND ACCESSORIES	118NOT LISTED	Division of Northern Border Imports (DNBI)
6/13/2011	74MHXMONITOR, PHYSIOLOGICAL, PATIENT	341REGISTERED	Florida District Office (FLA-DO)
6/13/2011	73KOISTIMULATOR, NERVE, PERIPHERAL, ELECTRIC	341REGISTERED	Florida District Office (FLA-DO)
6/13/2011	73CCLANALYZER, GAS, OXYGEN, GASEOUS-PHASE	341REGISTERED	Florida District Office (FLA-DO)
6/13/2011	74MHXMONITOR, PHYSIOLOGICAL, PATIENT	341REGISTERED	Florida District Office (FLA-DO)
6/13/2011	74MHXMONITOR, PHYSIOLOGICAL, PATIENT	341REGISTERED	Florida District Office (FLA-DO)
6/13/2011	84GWQELECTROENCEPHALOGRAPH	341REGISTERED	Florida District Office (FLA-DO)
11/23/2010	73LKDMONITOR, CARBON-DIOXIDE, CUTANEOUS	508NO 510(K)	Florida District Office (FLA-DO)
11/23/2010	73LKDMONITOR, CARBON-DIOXIDE, CUTANEOUS	508NO 510(K)	Florida District Office (FLA-DO)
11/23/2010	73LKDMONITOR, CARBON-DIOXIDE, CUTANEOUS	508NO 510(K)	Florida District Office (FLA-DO)
11/23/2010	73LKDMONITOR, CARBON-DIOXIDE, CUTANEOUS	508NO 510(K)	Florida District Office (FLA-DO)
11/23/2010	73LKDMONITOR, CARBON-DIOXIDE, CUTANEOUS	508NO 510(K)	Florida District Office (FLA-DO)
11/23/2010	73LKDMONITOR, CARBON-DIOXIDE, CUTANEOUS	508NO 510(K)	Florida District Office (FLA-DO)
5/13/2009	74MLDMONITOR, ST SEGMENT WITH ALARM	341REGISTERED	Florida District Office (FLA-DO)
5/13/2009	74MLDMONITOR, ST SEGMENT WITH ALARM	341REGISTERED	Florida District Office (FLA-DO)
10/23/2006	74MHXMONITOR, PHYSIOLOGICAL, PATIENT	47NON STD	Chicago District Office (CHI-DO)
10/23/2006	74MHXMONITOR, PHYSIOLOGICAL, PATIENT	47NON STD	Chicago District Office (CHI-DO)
6/19/2006	74MLOELECTROCARDIOGRAPH, AMBULATORY WITH ANALYSIS ALGORITHM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/19/2006	74MLOELECTROCARDIOGRAPH, AMBULATORY WITH ANALYSIS ALGORITHM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/19/2006	74MLNELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/19/2006	74MLOELECTROCARDIOGRAPH, AMBULATORY WITH ANALYSIS ALGORITHM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/19/2006	74MLOELECTROCARDIOGRAPH, AMBULATORY WITH ANALYSIS ALGORITHM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/19/2006	74MLOELECTROCARDIOGRAPH, AMBULATORY WITH ANALYSIS ALGORITHM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/19/2006	74MLOELECTROCARDIOGRAPH, AMBULATORY WITH ANALYSIS ALGORITHM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/13/2006	74MLOELECTROCARDIOGRAPH, AMBULATORY WITH ANALYSIS ALGORITHM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/13/2006	74MLOELECTROCARDIOGRAPH, AMBULATORY WITH ANALYSIS ALGORITHM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/8/2006	74MLOELECTROCARDIOGRAPH, AMBULATORY WITH ANALYSIS ALGORITHM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/1/2005	74DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR	118NOT LISTED	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is GE Healthcare Finland Oy's FDA import refusal history?

GE Healthcare Finland Oy (FEI: 3002806783) has 39 FDA import refusal record(s) in our database, spanning from 6/1/2005 to 1/19/2023.

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 Finland Oy's FEI number is 3002806783.

What types of violations has GE Healthcare Finland Oy received?

GE Healthcare Finland Oy has been cited for 5 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 Finland Oy come from?

All FDA import refusal data for GE Healthcare Finland Oy 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.