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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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Infúzní souprava pro gravitační infúze — 4 UDI-DI variants, MDR

MD Atlas
GAMA GROUP a.s.

Data from EUDAMED, last updated May 23, 2026

Infúzní souprava pro gravitační infúze

85935406TF02ISGRAVITACHE

4 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: GAMA GROUP a.s.

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 85935406TF02ISGRAVITACHE
Device name: Infúzní souprava pro gravitační infúze
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Feb 1, 2024

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

4 UDI-DI variants

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Applied filters

basicUdiUlid01HNCW60MTK0RN2ARAE61S2F3Y

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-10108593540508546
Infusion set IS-10208593540508560
Infusion set IS-10308593540507785
Infusion set IS-103 – pack. 4x50 pcs.08593540507808