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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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Empatica Care — 4 UDI-DI variants, MDR (Empatica S.r.L.)

MD Atlas
Empatica S.r.L.

Data from EUDAMED, last updated May 31, 2026

Empatica Care

0853858006CARE42

4 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: Empatica S.r.L.

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Device characteristics

Active device

Identity & classification

Basic UDI-DI: 0853858006CARE42
Device name: Empatica Care
Device model: Empatica Care - iOS Version
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: Jan 29, 2026

Manufacturer & authorised representative

Manufacturer

Name: Empatica S.r.L.
SRN: IT-MF-000012905
Country: Italy
Email: info@empatica.com

Variants by status

UDI-DI variants

4 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01KG4X6ZHJDYTQPY3PHRJ8HM8P

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

Care-AND00853858006256
PKG-AND00853858006706
PKG-IOS00853858006690
CARE-IOS00853858006249