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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® — 8 UDI-DI variants, IVDR (Tharmac GmbH)

MD Atlas
Tharmac GmbH

Data from EUDAMED, last updated May 23, 2026

GynoPrep®

426245825GP1G9

8 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

Professional testing

Identity & classification

Basic UDI-DI: 426245825GP1G9
Device name: GynoPrep®
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Dec 1, 2025

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

8 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01KBCW6F3J25PCVGYKNMBNZJZW

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

GynoPrep dilution fluid 30ml04262458250024
GynoPrep® 1 l04262458250048
GynoPrep® 10 ml04262458250017
GynoPrep® 1000 l04262458250079
GynoPrep® 20 ml04262458250000
GynoPrep® 30 l04262458250062
GynoPrep® 4.3 ml04262458250031
GynoPrep® 5 l04262458250055