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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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Infuzní souprava pro přetlakovou infuzi — 6 UDI-DI variants, MDR

MD Atlas
GAMA GROUP a.s.

Data from EUDAMED, last updated May 23, 2026

Infuzní souprava pro přetlakovou infuzi

85935406TF03ISPRETLAKKM

6 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: GAMA GROUP a.s.

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Device characteristics

Administers medicine

Legacy certificates

Certificate number: 26 0129 QR/NB
Type: refdata.certificate-mdr-type.quality-management-system
Notified body: INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390 (1023)
Validity: Apr 30, 2026 → Apr 29, 2031

Identity & classification

Basic UDI-DI: 85935406TF03ISPRETLAKKM
Device name: Infuzní souprava pro přetlakovou infuzi
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Jul 28, 2025

Manufacturer & authorised representative

Manufacturer

Name: GAMA GROUP a.s.
SRN: CZ-MF-000011894
Country: Czechia
Email: gama.jim@gama.cz

Variants by status

UDI-DI variants

6 UDI-DI variants

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Applied filters

basicUdiUlid01K17THWN1QBQ695CY0GM5K891

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

Infusion set IS-121 M08593540513304
Infusion set IS-123 M08593540513328
Infusion set IS-126 - 62 ShA M08593540513342
Infusion set IS-126T - 62 ShA M08593540513366
Infusion set IS-127 P® 180 cm M08593540513403
Infusion set IS-127 P® M08593540513380