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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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OTTIX SHAPER — 6 UDI-DI variants, IVDR

MD Atlas
Diapath S.p.A. società a socio unico

Data from EUDAMED, last updated May 30, 2026

OTTIX SHAPER

8033895W01030799OttixSQ7

6 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: Diapath S.p.A. società a socio unico

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Device characteristics

ReagentProfessional testing

Clinical investigations

Registered: No

Identity & classification

Basic UDI-DI: 8033895W01030799OttixSQ7
Device name: OTTIX SHAPER
Device model: XYLENE AND ALCOHOLS SUBSTITUTE - OTTIX SHAPER
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Apr 30, 2026

Manufacturer & authorised representative

Manufacturer

Name: Diapath S.p.A. società a socio unico
SRN: IT-MF-000027016
Country: Italy
Email: info@diapath.com
Phone: +39 0363986411

Variants by status

UDI-DI variants

6 UDI-DI variants

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Applied filters

basicUdiUlid01KQF68RS5TRRJ3GXASQ374K0W

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

DONATELLO SERIES TANK_OTTIX SHAPER08033895049085
DONATELLO TANK_OTTIX SHAPER 4.1 LT08033895009256
OTTIX SHAPER 2.5 LT08033895010283
OTTIX SHAPER 5 LT08033895012577
OTTIX SHAPER 1 LT08033895012553
OTTIX SHAPER 10 LT08033895010306