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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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Organization name
UDI-DI code
Reference / catalog number

GENSPEED R2 Analyzer — IVDR Class A IVDR by GENSPEED Biotech

MD Atlas
GENSPEED Biotech

EUDAMED last updated this device on Apr 27, 2026

GENSPEED R2 Analyzer

912013177R2analyzerL7

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: GENSPEED Biotech
UDI-DI code: 09120131770014
Reference / catalog number: GSHW001

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Manufacturer information

Organization name: GENSPEED Biotech
SRN: AT-MF-000013008
Manufacturer status: Active

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Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Austria; available across 1 country total.

Country	On market since	Until
AustriaPrimary placement	May 9, 2025	Still on market

Device identification

Trade name: GENSPEED R2 Analyzer
UDI-DI code: 09120131770014
Basic UDI-DI: 912013177R2analyzerL7
Reference / catalog number: GSHW001
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The GENSPEED R2 Analyzer is an automated in vitro diagnostic system for the analysis of human samples with the GENSPEED test kits by healthcare professionals at the point of care.
Additional information URL: https://www.genspeed-biotech.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201069099VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Manufacturing date
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Software identification

Certificates

Certificate health across this manufacturer's portfolio.

ITDA/00002/0v003Issued
refdata.certificate-ivdr-type.technical-documentationNotified body: 2962Expiry: Sep 4, 2029
IQMS/00002/0v001Issued
refdata.certificate-ivdr-type.quality-management-systemNotified body: 2962Expiry: Sep 4, 2029