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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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Rigenera machine EVO — 1 UDI-DI variant, MDR (HUMAN BRAIN WAVE SRL)

MD Atlas
HUMAN BRAIN WAVE SRL

Data from EUDAMED, last updated May 30, 2026

Rigenera machine EVO

805848167N4SAEVOS5

1 UDI-DI variant

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: HUMAN BRAIN WAVE SRL

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Device characteristics

Active device

Identity & classification

Basic UDI-DI: 805848167N4SAEVOS5
Device name: Rigenera machine EVO
Device model: N4SA EVO
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Mar 31, 2026

Manufacturer & authorised representative

Manufacturer

Name: HUMAN BRAIN WAVE SRL
SRN: IT-MF-000010074
Country: Italy
Email: letizia.trovato@hbwsrl.com
Phone: + 39 011 9934508

Variants by status

UDI-DI variants

1 UDI-DI variant

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Export results

Applied filters

basicUdiUlid01KN21B1GXNZY732PVFTCM1NFQ

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

N$SAEVO08058481670153