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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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GEMINI LS — 4 UDI-DI variants, MDR (SITIN LAB s.r.o.)

MD Atlas
SITIN LAB s.r.o.

Data from EUDAMED, last updated May 31, 2026

GEMINI LS

859421190007H5

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: SITIN LAB s.r.o.

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 859421190007H5
Device name: GEMINI LS
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: May 26, 2026

Manufacturer & authorised representative

Manufacturer

Name: SITIN LAB s.r.o.
SRN: CZ-MF-000023036
Country: Czechia
Email: info@geminisystem.cz
Phone: +420 602 223 728

Variants by status

UDI-DI variants

4 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01KSHH2A51A9Y616MSCRTZDK35

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

K-231005-00408594211900096
K-231005-00308594211900072
K-231005-004-V08594211900102
K-231005-003-V08594211900089