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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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RapidHemo Integrated Analyzer — 2 UDI-DI variants, IVDR

MD Atlas
ZOVEC diagnostics GmbH

Data from EUDAMED, last updated May 23, 2026

RapidHemo Integrated Analyzer

426257539RapidHemoHNL

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: ZOVEC diagnostics GmbH

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Device characteristics

Professional testing

Clinical investigations

Registered: No

Identity & classification

Basic UDI-DI: 426257539RapidHemoHNL
Device name: RapidHemo Integrated Analyzer
Device model: RapidHemo
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Mar 17, 2026

Manufacturer & authorised representative

Manufacturer

Name: ZOVEC diagnostics GmbH
SRN: DE-MF-000035393
Country: Germany
Email: wgottstein@aol.com
Phone: #49 621 76441010

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01KKXM82Z2E2JJBANJ1H0X0H4F

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

RapidHemo42625753900092
RapidHemo Reagent42625753900160