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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Portrait Wearable Pulse Oximetry Sensors — 4 UDI-DI variants, MDR

MD Atlas
GE Healthcare Finland Oy

Data from EUDAMED, last updated May 23, 2026

Portrait Wearable Pulse Oximetry Sensors

8406821BUG00260H8

4 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIb

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Manufacturer: GE Healthcare Finland Oy

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Device characteristics

Active deviceMeasuring function

Identity & classification

Basic UDI-DI: 8406821BUG00260H8
Device name: Portrait Wearable Pulse Oximetry Sensors
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Version date: Apr 21, 2022

Manufacturer & authorised representative

Manufacturer

Name: GE Healthcare Finland Oy
SRN: FI-MF-000001176
Country: Finland
Email: eudamed@gehealthcare.com

Variants by status

UDI-DI variants

4 UDI-DI variants

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Applied filters

basicUdiUlid01G0C4XCR9XGB46N84Y55A0SP9

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

Portrait SpO2 P-SA0100195278264831
Portrait SpO2 P-SE0100195278264824
Portrait SpO2 P-SP0100195278264794
Portrait SpO2 P-W0100195278264800