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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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Software Hi — 4 UDI-DI variants, IVDR (Edif Instruments S.r.l.)

MD Atlas
Edif Instruments S.r.l.

Data from EUDAMED, last updated May 30, 2026

Software Hi

805360894SFT-HIGD

4 UDI-DI variants

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

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Manufacturer: Edif Instruments S.r.l.

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 805360894SFT-HIGD
Device name: Software Hi
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Special device type: refdata.special-ivd-device-type.software
Version date: May 25, 2022

Manufacturer & authorised representative

Manufacturer

Name: Edif Instruments S.r.l.
SRN: IT-MF-000009556
Country: Italy
Email: info@edif.it

Variants by status

UDI-DI variants

4 UDI-DI variants

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Applied filters

basicUdiUlid01G3XY58CEF4WEG2DDWBBKNZW7

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

Software Hi80536089418260
Software Hi Version 1.280536089418192
Software Hi Version 1.480536089418024
Software Hi Version 1.580536089417966