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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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FetoGnost® Kit RHD — 2 UDI-DI variants, IVDR (Ingenetix GmbH)

MD Atlas
Ingenetix GmbH

Data from EUDAMED, last updated May 23, 2026

FetoGnost® Kit RHD

912011050HUFGRXX8D

2 UDI-DI variants

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class D

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class D
Manufacturer: Ingenetix GmbH

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Device characteristics

ReagentProfessional testing

Clinical investigations

Registered: No

Legacy certificates

Certificate number: ITDA/00005/0v001
Type: refdata.certificate-ivdr-type.technical-documentation
Notified body: QMD Services GmbH (2962)
Validity: Mar 3, 2026 → Mar 2, 2031

Identity & classification

Basic UDI-DI: 912011050HUFGRXX8D
Device name: FetoGnost® Kit RHD
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class D
Version date: Jul 5, 2024

Manufacturer & authorised representative

Manufacturer

Name: Ingenetix GmbH
SRN: AT-MF-000001501
Country: Austria
Email: office@ingenetix.com
Phone: +431361980198

Variants by status

UDI-DI variants

2 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01J20ZJCN2AYV7AEV9ZEY0CG7K

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

HUFG50009120110506405
HUFG10009120110505897