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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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R-EVO SMART CR — 3 UDI-DI variants, MDR (Optikon 2000 S.p.A.)

MD Atlas
Optikon 2000 S.p.A.

Data from EUDAMED, last updated May 30, 2026

R-EVO SMART CR

8059308EQ_SMR_004PS

3 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Manufacturer: Optikon 2000 S.p.A.

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Device characteristics

Active device

Identity & classification

Basic UDI-DI: 8059308EQ_SMR_004PS
Device name: R-EVO SMART CR
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Version date: Apr 28, 2026

Manufacturer & authorised representative

Manufacturer

Name: Optikon 2000 S.p.A.
SRN: IT-MF-000017618
Country: Italy
Email: mronchetti@bvimedical.com
Phone: +39 06 8888410

Variants by status

UDI-DI variants

3 UDI-DI variants

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Applied filters

basicUdiUlid01KQA5751E4G5JF2JBYPK4V2GX

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

12101308059308000900
11100908059308000047
11101008059308000054