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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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iCare PATIENT2 — 2 UDI-DI variants, MDR (Icare Finland Oy)

MD Atlas
Icare Finland Oy

Data from EUDAMED, last updated May 23, 2026

iCare PATIENT2

643003385TS057X

2 UDI-DI variants

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

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

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Device characteristics

Active device

Legacy certificates

Certificate number: FI22/00000011
Type: refdata.certificate-mdr-type.quality-management-system
Notified body: SGS FIMKO OY (0598)
Validity: Oct 7, 2025 → Oct 6, 2030

Identity & classification

Basic UDI-DI: 643003385TS057X
Device name: iCare PATIENT2
Device model: TS05
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Special device type: refdata.special-mdr-device-type.software
Version date: May 31, 2023

Manufacturer & authorised representative

Manufacturer

Name: Icare Finland Oy
SRN: FI-MF-000000501
Country: Finland
Email: customercare@icare-world.com
Phone: +358987751150

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01H1RNCGRQJMQB7EBZR558RVKF

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

iCare PATIENT206430033851104
iCare PATIENT206430033851098