GE Healthcare Finland Oy

Certificate CR-03-1004-836-24

Rev. 04Supplemented

Valid until: Feb 8, 2027

Certificate CR-03-1004-836-24 is a valid Quality management system issued to GE Healthcare Finland Oy and registered in EUDAMED. Valid until February 8, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: CR-03-1004-836-24
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 11
Certificate ID: 0537CR-03-1004-836-2404

Validity

Issued: Dec 8, 2025
Valid from: Dec 8, 2025
Valid until: Feb 8, 2027

Notified body

Notified body: Eurofins Electric & Electronics Finland Oy
Notified body SRN: 0537
Notified body country: Finland

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Class IIb only

History

Status changes

Supplemented
Supplemented

Supersedes

CR-03-1004-836-24Quality management systemSupplementedOct 6, 2025 → Feb 8, 2027

Scope coverage

Class IIb36Class IIa5

41 scopes

MDA 0315 Software
Class IIa
MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
Class IIb
MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care.
Class IIa
Centricity High Acuity Anesthesia
Class IIa
Centricity High Acuity Critical Care
Class IIa
CARESCAPE B850
Class IIb
CARESCAPE Software
Class IIb
CARESCAPE Interface module: E-musb
Class IIb
E-Module Frames
Class IIb
CARESCAPE B450
Class IIb
CARESCAPE B650
Class IIb
Portrait Mobile Patient Monitor
Class IIb
Portrait Wearable Pulse Oximetry Sensors
Class IIb
Portrait Wearable Respiration Rate Sensor
Class IIb
Portrait Sensor Battery
Class IIb
Displays for monitoring systems
Class IIb
Carescape Canvas Smart Display
Class IIb
Carescape Canvas 1000
Class IIb
Carescape Software
Class IIb
CARESCAPE Canvas D19
Class IIb

1 / 3

Documents

LanguagesEN

Scope coverage

Class IIb36Class IIa5

41 scopes

MDA 0315 Software
Class IIa
MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
Class IIb
MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care.
Class IIa
Centricity High Acuity Anesthesia
Class IIa
Centricity High Acuity Critical Care
Class IIa
CARESCAPE B850
Class IIb
CARESCAPE Software
Class IIb
CARESCAPE Interface module: E-musb
Class IIb
E-Module Frames
Class IIb
CARESCAPE B450
Class IIb
CARESCAPE B650
Class IIb
Portrait Mobile Patient Monitor
Class IIb
Portrait Wearable Pulse Oximetry Sensors
Class IIb
Portrait Wearable Respiration Rate Sensor
Class IIb
Portrait Sensor Battery
Class IIb
Displays for monitoring systems
Class IIb
Carescape Canvas Smart Display
Class IIb
Carescape Canvas 1000
Class IIb
Carescape Software
Class IIb
CARESCAPE Canvas D19
Class IIb

1 / 3

Certificate CR-03-1004-836-24

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate CR-03-1004-836-24

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer