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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

A8592 — IVDR Class A IVDR by R-Biopharm AG

MD Atlas
R-Biopharm AG

EUDAMED last updated this device on Nov 6, 2023

A8592

4049095A859200000SU

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: R-Biopharm AG
UDI-DI code: 04049095012303
Reference / catalog number: A8592

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Manufacturer information

Organization name: R-Biopharm AG
SRN: DE-MF-000007993
Manufacturer status: Active

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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.

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 04049095012303
Basic UDI-DI: 4049095A859200000SU
Reference / catalog number: A8592
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: Für in vitro Diagnostik. Die RIDASOFT® FoodGuide Software ist eine Messdatenerfassungs- und Auswertesoftware. Sie kann Messdaten auf zwei Wegen erfassen. A) In Form von optischer Dichte Messdaten, welche mit ELISA Messgeräten gemessen worden sind; und B) in Form von grafischen Bildern, welche von angeschlossenen Mikroarray-Messgeräten erfasst werden. Die aufgenommenen Messdaten werden anschließend entsprechend der Vorgaben des entsprechenden IVD Tests bewertet. Die berechneten Konzentrationen werden gemäß der Vorgaben des IVD Tests bewertet. Die berechneten Werte werden schlussendlich in Verbindung mit Patienten- und Therapeutendaten in einem grafischen Bericht ausgegeben.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02079082VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - SOFTWARE ACCESSORIES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification