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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 1 of 6

Device	Model / Reference	Registries	Class	Status
Carescape	Monitor B650-LI	FDA UDI	Class II	Active
Carescape	Monitor B850-LI	FDA UDI	Class II	Active
Carescape B650	MBB313	EUDAMEDFDA UDI	Class II	Active
Carescape	Monitor B450	FDA UDI	Class II	Active
Carescape	Monitor B850 CPU-C1	FDA UDI	Class II	Active
Carescape	Monitor B650	FDA UDI	Class II	Active
Carescape	Monitor B450-LI	FDA UDI	Class II	Active
OxyTip SpO2	OXY-WMR-00	FDA UDI	Class II	Active
E-Eegx	MJD101	FDA UDI	Class II	Active
OxyTip SpO2	OXY-FMR-00	FDA UDI	Class II	Active
N-Eegx	MJS101	FDA UDI	Class II	Active
TruSignal SpO2	TS-F4-MC	FDA UDI	Class II	Unknown
Carescape B450	MBA313	FDA UDI	Class II	Active
CARESCAPE Canvas Smart Display	5897060	FDA UDI	Class II	Active
Carescape Monitor B650	K131223	FDA 510(k)	Class II	Active
Carescape B650	K191149	FDA 510(k)	Class II	Active
Carescape Monitor B650	K102239	FDA 510(k)	Class II	Active
Portrait MMP01	5514246-30	EUDAMEDFDA UDI	Class I	Active
ECG Trunk Cables and Leadwires	2106398-003	EUDAMEDFDA UDI	Class I	Active
D-lite+ Spirometry Kit, adult, 2m/7ft	8004381	EUDAMEDFDA UDI	Class IIa	Active
TruSignal SpO2 Resusable Sensor, Finger, Adult/Pediatric, 1M	TS-F-D	EUDAMEDFDA UDI	Class IIb	Active
B650 Software Upgrade	2107843-001	EUDAMED	Class IIb	Active
ECG Trunk Cables and Leadwires	2106394-002	EUDAMEDFDA UDI	Class I	Active
Invasive Blood Pressure Trunk Cables	2104162-002	EUDAMEDFDA UDI	Class I	Active
Centricity™ High Acuity Anesthesia	K1900EAED	EUDAMED	Class I	Active
Gas Sampling Line, disposable, PVC/PE, 6m/20ft	2097307-003	EUDAMEDFDA UDI	Class IIa	Active
ECG Trunk Cables and Leadwires	2106394-001	EUDAMEDFDA UDI	Class I	Active
Ear Tips for AEP Earphone	8001233	EUDAMEDFDA UDI	Class IIb	Active
USB Remote Control	2039040-008	EUDAMED	Class I	Active
TruSignal SPO2 Trunk Cable with TruSat connector	TS-M3	EUDAMEDFDA UDI	Class IIb	Active
Pre-configured EEG Lead Set 3, AEP	898052	EUDAMEDFDA UDI	Class IIb	Active
D-fend Water Trap, black	876446-HEL	EUDAMEDFDA UDI	Class IIa	Active
Portrait SBT01	2096442-001	EUDAMEDFDA UDI	Class IIb	Active
Portrait HUBXB	5923524	EUDAMEDFDA UDI	Class IIb	Active
ECG Trunk Cables and Leadwires	2106306-001	EUDAMEDFDA UDI	Class I	Active
PiCCO Continuous Cardiac Output Cable, 4.1m	M1154585	EUDAMEDFDA UDI	Class IIb	Active
B450 Software Upgrade	2107844-001	EUDAMED	Class IIb	Active
Invasive Blood Pressure Trunk Cables	2104107-001	EUDAMEDFDA UDI	Class I	Active
ECG Trunk Cables and Leadwires	2106385-002	EUDAMEDFDA UDI	Class I	Active
ECG Trunk Cables and Leadwires	2106310-002	EUDAMEDFDA UDI	Class I	Active
Portrait RRP01	5514119	EUDAMEDFDA UDI	Class I	Active
TruSignal Attachment Accessories	TS-HB-3	EUDAMEDFDA UDI	Class I	Active
Centricity High Acuity Critical Care	K1900AB, K1900EHED, K1900EKED, K1900ENED, K1900EQED, K1900ESED, K1900EUED	EUDAMED	Class IIa	Active
ECG Trunk Cables and Leadwires	2106308-003	EUDAMEDFDA UDI	Class I	Active
ECG Trunk Cables and Leadwires	2106383-002	EUDAMEDFDA UDI	Class I	Active
ECG Trunk Cables and Leadwires	2106397-002	EUDAMEDFDA UDI	Class I	Active
Invasive Blood Pressure Trunk Cables	2104166-002	EUDAMEDFDA UDI	Class I	Active
TruSignal PRES MM	5700393	EUDAMED	Class IIb	Active
TruSignal SpO2 Disposable Sensor, Pediatric/Infant, 0.3M	TS-AP-xx	EUDAMEDFDA UDI	Class IIb	Active
E-Picco Continuous Cardiac Output Module And Accessories	K132528	FDA 510(k)	Class II	Active

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