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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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GynoPrep Selfsampling Set — 2 UDI-DI variants, IVDR (Tharmac GmbH)

MD Atlas
Tharmac GmbH

Data from EUDAMED, last updated May 23, 2026

GynoPrep Selfsampling Set

426245825GSSSE8

2 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: Tharmac GmbH

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Device characteristics

ReagentSelf-testing

Identity & classification

Basic UDI-DI: 426245825GSSSE8
Device name: GynoPrep Selfsampling Set
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Feb 4, 2026

Manufacturer & authorised representative

Manufacturer

Name: Tharmac GmbH
SRN: DE-MF-000039165
Country: Germany
Email: info@tharmac.de
Phone: +49 6431 5 84 88 18

Variants by status

UDI-DI variants

2 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01KGM9Y1SZ6T0FG554D2JX31BN

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

360S-1-004262458250932
360S-1-004262458250949