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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 5 of 6

Device	Model / Reference	Registries	Class	Status
Gas exhaust lines	5514183	EUDAMEDFDA UDI	Class IIa	Active
ECG Trunk Cables and Leadwires	2106305-003	EUDAMEDFDA UDI	Class I	Active
E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE, N-CAiO	E-sCO-00	EUDAMEDFDA UDI	Class IIb	Active
USB Remote Control	2039040-007	EUDAMED	Class I	Active
Centricity™ High Acuity (CHA) Critical Care	K1900EBED	EUDAMED	Class I	Active
PiCCO Cables	M1182448	EUDAMED	Class I	Active
Invasive Blood Pressure Trunk Cables	2103966-001	EUDAMEDFDA UDI	Class I	Active
Invasive Blood Pressure Trunk Cables	2104162-001	EUDAMEDFDA UDI	Class I	Active
TruSignal Attachment Accessories	TS-RWL-24	EUDAMEDFDA UDI	Class I	Active
Carescape Canvas Smart Display	5962265	EUDAMEDFDA 510(k)FDA UDI	Class IIb	Active
E-Eegx	E-EEGX	EUDAMED	Class IIb	Active
N-CAiO	N-CAiO-00	EUDAMEDFDA UDI	Class IIb	Active
ECG Trunk Cables and Leadwires	2106306-003	EUDAMEDFDA UDI	Class I	Active
Pedi-lite+ Sensor, disposable, pediatric	8001948	EUDAMEDFDA UDI	Class IIa	Active
Invasive Blood Pressure Trunk Cables	2104166-001	EUDAMEDFDA UDI	Class I	Active
Centricity High Acuity Anesthesia	K1900A, K1900AA, K1900EGED, K1900EJED, K1900EMED, K1900EPED, K1900ERED, K1900ETED	EUDAMED	Class IIa	Active
ECG Trunk Cables and Leadwires	2106393-003	EUDAMEDFDA UDI	Class I	Active
E-PiCCO	E-PiCCO-00	EUDAMEDFDA UDI	Class IIb	Active
USB Remote Control	2039040-001	EUDAMEDFDA UDI	Class I	Active
ECG Trunk Cables and Leadwires	2106381-002	EUDAMEDFDA UDI	Class I	Active
ECG Trunk Cables and Leadwires	2106307-004	EUDAMEDFDA UDI	Class I	Active
TruSignal SpO2 Resusable Sensor, Ear, Adult/Pediatric, 1M	TS-E-D	EUDAMEDFDA UDI	Class IIb	Active
Pre-configured EEG Lead Set 1, basic	898050	EUDAMEDFDA UDI	Class IIb	Active
E-sCAiOE	E-sCAiOE-00	EUDAMEDFDA UDI	Class IIb	Active
E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE, N-CAiO	E-sCOV-00	EUDAMEDFDA UDI	Class IIb	Active
TruSignal SpO2 Interconnect Cable	TS-G3	EUDAMEDFDA UDI	Class I	Active
TruSignal Integrated SpO2 Resusable Sensor, Ohmeda, Finger, Adult, 1M	TS-F1-H	EUDAMEDFDA UDI	Class IIb	Active
ECG Trunk Cables and Leadwires	2106403-002	EUDAMEDFDA UDI	Class I	Active
TruSignal Integrated SpO2 Resusable Sensor, Datex, Finger, Adult, 4M	TS-F4-N	EUDAMEDFDA UDI	Class IIb	Active
E-Nsatx	E-NSATX-01	EUDAMEDFDA UDI	Class IIb	Active
E-sCAiO	E-sCAiO-00	EUDAMEDFDA UDI	Class IIb	Active
PiCCO Cables	M1154585	EUDAMED	Class I	Active
ECG Trunk Cables and Leadwires	2106403-003	EUDAMEDFDA UDI	Class I	Active
ECG Trunk Cables and Leadwires	2106389-005	EUDAMEDFDA UDI	Class I	Active
ECG Trunk Cables and Leadwires	2106403-001	EUDAMEDFDA UDI	Class I	Active
GE Entropy Cable, 3, 5 m	M1050784	EUDAMEDFDA UDI	Class IIb	Active
PiCCO Injectate Sensor Cable, 0.9m	M1182448	EUDAMEDFDA UDI	Class IIb	Active
NMT Sensor Cable, 3, 3 m	888414	EUDAMEDFDA UDI	Class IIa	Active
ECG Trunk Cables and Leadwires	2106306-004	EUDAMEDFDA UDI	Class I	Active
TruSignal Integrated SpO2 Resusable Sensor, GE, Ear, Adult/Pediatric, 2M	TS-E2-GE	EUDAMEDFDA UDI	Class IIb	Active
TruSignal Attachment Accessories	TS-RWS-24	EUDAMEDFDA UDI	Class I	Active
Invasive Blood Pressure Trunk Cables	2104166-003	EUDAMEDFDA UDI	Class I	Active
ECG Trunk Cables and Leadwires	2106311-001	EUDAMEDFDA UDI	Class I	Active
TruSignal SpO2 MM 1.8M	5956015	EUDAMED	Class IIb	Active
ECG Trunk Cables and Leadwires	2106305-002	EUDAMEDFDA UDI	Class I	Active
E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE, N-CAiO	E-sCAiOVX-00	EUDAMEDFDA UDI	Class IIb	Active
Spirometry Tube, disposable, 2m/7ft	890031	EUDAMEDFDA UDI	Class IIa	Active
TruSignal Integrated SpO2 Resusable Sensor, GE, Finger, Adult, 4M	TS-F4-GE	EUDAMEDFDA UDI	Class IIb	Active
Carescape	5514366	EUDAMEDFDA UDI	Class IIb	Active
Portrait SpO2 P-W01	2096441-001	EUDAMEDFDA UDI	Class IIb	Active

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