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Ge Healthcare Filand OY

Finland·FI-MF-000001176

Last updated May 23, 2026

What Ge Healthcare Filand OY makes

The company manufactures the E-ENTROPY-01, an Entropy Module designed for monitoring patient brain function during surgical procedures, particularly in neuroanesthesia and critical care settings.

This device is classified as Class II under FDA regulations and is listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Ge Healthcare Filand OY manufacture?

Ge Healthcare Filand OY manufactures the E-ENTROPY-01, an Entropy Module specifically designed to monitor patient brain function during surgeries, particularly in neuroanesthesia and critical care environments. This device helps assess cerebral function by measuring brain activity, aiding clinicians in making real-time clinical decisions.

Where is Ge Healthcare Filand OY based?

Ge Healthcare Filand OY is based in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with U.S. medical device standards.

How are the devices manufactured by Ge Healthcare Filand OY classified under FDA regulations?

The E-ENTROPY-01 Entropy Module is classified as a Class II device under FDA regulations. This classification indicates it poses moderate risk and requires special controls to ensure its safety and effectiveness, beyond general controls like good manufacturing practices.

Are the devices produced by Ge Healthcare Filand OY listed in any regulatory registries?

Yes, the E-ENTROPY-01 Entropy Module is listed in the FDA’s 510(k) registry. This registry includes devices that have undergone a premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device, ensuring compliance with FDA requirements.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: Finland
Address: 2, Kuortaneenkatu, HELSINKI, Finland
Website: gehealthcare.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Tarja Päivinen
EUDAMED SRN: FI-MF-000001176
FDA FEI Number: —
DUNS Number: —

Catalogue (292)

Page 6 of 6

Device	Model / Reference	Registries	Class	Status
E-Masimo	E-MASIMO-00	EUDAMEDFDA UDI	Class IIb	Active
ECG Trunk Cables and Leadwires	2106307-002	EUDAMEDFDA UDI	Class I	Active
ECG Trunk Cables and Leadwires	2106305-004	EUDAMEDFDA UDI	Class I	Active
TruSignal SpO2 Resusable Sensor, Finger, Adult, 1M	TS-SA-D	EUDAMEDFDA UDI	Class IIb	Active
D-lite++ Patient Spirometry Set, 2 m/7 ft	2104297-001	EUDAMEDFDA UDI	Class IIa	Active
USB Remote Control	2039040-004	EUDAMED	Class I	Active
Mobile Care, Web Viewer	Mobile Care Software Licenses	EUDAMEDFDA UDI	Class IIb	Active
ECG Trunk Cables and Leadwires	2106310-001	EUDAMEDFDA UDI	Class I	Active
Centricity High Acuity	K1900CYED	EUDAMED	Class IIa	Active
Carescape Rad	CARESCAPE RAD	EUDAMEDFDA UDI	Class IIb	Active
Centricity™ High Acuity Anesthesia	K1900ECED	EUDAMED	Class I	Active
ECG Trunk Cables and Leadwires	2106391-003	EUDAMEDFDA UDI	Class I	Active
ECG Trunk Cables and Leadwires	2106383-003	EUDAMEDFDA UDI	Class I	Active
ECG Trunk Cables and Leadwires	2106390-003	EUDAMEDFDA UDI	Class I	Active
ECG Trunk Cables and Leadwires	2106381-004	EUDAMEDFDA UDI	Class I	Active
D-lite++ Patient Spirometry Set, 3 m/10 ft	2104297-002	EUDAMEDFDA UDI	Class IIa	Active
E-Pt	E-PT-00	EUDAMEDFDA UDI	Class IIb	Active
Gas exhaust line, white conical and Colder, disposable, 1 m/3.3 ft	5514182	EUDAMEDFDA UDI	Class IIa	Active
USB Remote Control	2039040-002	EUDAMED	Class I	Active
ECG Trunk Cables and Leadwires	2106397-003	EUDAMEDFDA UDI	Class I	Active
D-lite Sensor, reusable, adult	733910-HEL	EUDAMEDFDA UDI	Class IIa	Active
Invasive Blood Pressure Trunk Cables	2104107-002	EUDAMEDFDA UDI	Class I	Active
Nellcor Compatible SpO2 Interconnect Cables	2021406-001	EUDAMEDFDA UDI	Class I	Active
Nellcor Compatible SpO2 Interconnect Cables	2025350-001	EUDAMEDFDA UDI	Class I	Active
ECG Trunk Cables and Leadwires	2106308-002	EUDAMEDFDA UDI	Class I	Active
D-fend+ Water Trap, green	881319-HEL	EUDAMEDFDA UDI	Class IIa	Active
ECG Trunk Cables and Leadwires	2106391-004	EUDAMEDFDA UDI	Class I	Active
ECG Trunk Cables and Leadwires	2106307-001	EUDAMEDFDA UDI	Class I	Active
Mini D-fend water trap	8002174	EUDAMEDFDA UDI	Class I	Active
E-sCAiOV	E-sCAiOV-00	EUDAMEDFDA UDI	Class IIb	Active
ECG Trunk Cables and Leadwires	2106390-004	EUDAMEDFDA UDI	Class I	Active
TruSignal Integrated SpO2 Resusable Sensor, GE, Ear, Adult/Pediatric, 4M	TS-E4-GE	EUDAMEDFDA UDI	Class IIb	Active
Carescape Software	5956035	EUDAMED	Class IIb	Active
TruSignal Attachment Accessories	TS-RT-100	EUDAMEDFDA UDI	Class I	Active
E-musb	E-musb	EUDAMEDFDA UDI	Class IIb	Active
Patient Spirometry Tubes	891191-HEL	EUDAMEDFDA UDI	Class I	Active
E-Entropy	E-ENTROPY-01	EUDAMEDFDA UDI	Class IIb	Active
ECG Trunk Cables and Leadwires	2106394-004	EUDAMEDFDA UDI	Class I	Active
E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE, N-CAiO	E-sCAiOVE-00	EUDAMEDFDA UDI	Class IIb	Active
USB Remote Control	2039040-018	EUDAMED	Class I	Active
TruSignal Attachment Accessories	TS-SND-3	EUDAMEDFDA UDI	Class I	Active
USB Remote Control	2039040-009	EUDAMED	Class I	Active

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