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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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eVai — 1 UDI-DI variant, IVDR (ENGENOME srl)

MD Atlas
ENGENOME srl

Data from EUDAMED, last updated May 31, 2026

eVai

805620972eVaiQN

1 UDI-DI variant

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class C

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Manufacturer: ENGENOME srl

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Device characteristics

Professional testing

Identity & classification

Basic UDI-DI: 805620972eVaiQN
Device name: eVai
Device model: eVai
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Special device type: refdata.special-ivd-device-type.software
Version date: Mar 24, 2026

Manufacturer & authorised representative

Manufacturer

Name: ENGENOME srl
SRN: IT-MF-000029171
Country: Italy
Email: amministrazione@engenome.com

Variants by status

UDI-DI variants

1 UDI-DI variant

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Export results

Applied filters

basicUdiUlid01KMFGHDKGM3V8T9H8KD1KGFB0

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

eVai08056209720104