Ge Healthcare

⚠️ Moderate Risk

FEI: 3004735094 • Helsinki, Uusimaa • FINLAND

FEI

FEI Number

3004735094

📍

Location

Helsinki, Uusimaa

🇫🇮

Country

FINLAND

🏢

Address

Aleksis Kiven Katu 3-5, , Helsinki, Uusimaa, Finland

Moderate Risk

FDA Import Risk Assessment

41.9

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

10/4/2005

Latest Refusal

10/6/2004

Earliest Refusal

Score Breakdown

Violation Severity

47.8×40%

Refusal Volume

42.5×30%

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

34111×

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).

5085×

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.

752×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

Date	Product	Violations	Division
10/4/2005	74MLDMONITOR, ST SEGMENT WITH ALARM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/14/2005	73BZKSPIROMETER, MONITORING (W/WO ALARM)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/14/2005	73BZKSPIROMETER, MONITORING (W/WO ALARM)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/14/2005	73CAPMONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
5/4/2005	73BZGSPIROMETER, DIAGNOSTIC	75UNAPPROVED	Florida District Office (FLA-DO)
5/4/2005	73BZGSPIROMETER, DIAGNOSTIC	75UNAPPROVED	Florida District Office (FLA-DO)
1/19/2005	74DPSELECTROCARDIOGRAPH	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/6/2004	84GWQELECTROENCEPHALOGRAPH	341REGISTERED	Florida District Office (FLA-DO)
10/6/2004	73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	341REGISTERED	Florida District Office (FLA-DO)
10/6/2004	73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	341REGISTERED	Florida District Office (FLA-DO)
10/6/2004	74MWJELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)	341REGISTERED	Florida District Office (FLA-DO)
10/6/2004	74MHXMONITOR, PHYSIOLOGICAL, PATIENT	341REGISTERED	Florida District Office (FLA-DO)
10/6/2004	73KOISTIMULATOR, NERVE, PERIPHERAL, ELECTRIC	341REGISTERED	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Ge Healthcare's FDA import refusal history?

Ge Healthcare (FEI: 3004735094) has 13 FDA import refusal record(s) in our database, spanning from 10/6/2004 to 10/4/2005.

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's FEI number is 3004735094.

What types of violations has Ge Healthcare received?

Ge Healthcare 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 Ge Healthcare come from?

All FDA import refusal data for Ge Healthcare 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.