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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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EVO-FIX Opaska do mocowania rurek… — 7 UDI-DI variants, MDR

MD Atlas
SINMED SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

Data from EUDAMED, last updated May 31, 2026

EVO-FIX Opaska do mocowania rurek tracheostomijnych

590371931001210029B

7 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: SINMED SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 590371931001210029B
Device name: EVO-FIX Opaska do mocowania rurek tracheostomijnych
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Sep 23, 2025

Manufacturer & authorised representative

Manufacturer

Name: SINMED SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
SRN: PL-MF-000002789
Country: Poland
Email: biuro@sinmed.pl
Phone: +48 32 729 82 36

Variants by status

UDI-DI variants

7 UDI-DI variants

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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

EVO-FIX One-piece tracheostomy tube holder59037193052666
EVO-FIX One-piece tracheostomy tube holder59037193060418
EVO-FIX One-piece tracheostomy tube holder59037193059382
EVO-FIX One-piece tracheostomy tube holder59037193052420
EVO-FIX One-piece tracheostomy tube holder59037193059900
EVO-FIX One-piece tracheostomy tube holder59037193059696
EVO-FIX Two-piece tracheostomy tube holder59037193059078