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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

CGRT6/96 — IVDR Class A IVDR by GeneProof a.s.

MD Atlas
GeneProof a.s.

EUDAMED last updated this device on May 25, 2026

CGRT6/96

859569630077R4

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: GeneProof a.s.
UDI-DI code: 08595696305772
Reference / catalog number: CGRT6/96

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Manufacturer information

Organization name: GeneProof a.s.
SRN: CZ-MF-000002370
Manufacturer status: Active

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

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 Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement		Still on market
Slovakia		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08595696305772
Basic UDI-DI: 859569630077R4
Reference / catalog number: CGRT6/96
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 croGENE Real-time PCR system is an automated instrument used for qualitative and quantitative detection of nucleic acid (DNA/RNA) using polymerase chain reaction process. The instrument is intended for molecular biology applications and for in vitro diagnostics. This product is not intended for the establishment of a diagnosis, prevention, or treatment of a disease. The croGENE Real-time PCR system is a fluorescent quantitative detection system. The instrument is intended for use in medical and biological laboratories by trained staff of clinical laboratories in molecular biological techniques. The product is intended to be used in combination with real-time PCR kits.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02050192NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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