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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

G09036 — IVDR Class B IVDR by R-Biopharm AG

MD Atlas
R-Biopharm AG

EUDAMED last updated this device on Feb 3, 2023

G09036

4049095G090360000SL

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: R-Biopharm AG
UDI-DI code: 04049095070051
Reference / catalog number: G09036

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Manufacturer information

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

Critical warnings

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

CW999
For warnings and precautions see IFU

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04049095070051
Basic UDI-DI: 4049095G090360000SL
Reference / catalog number: G09036
Issuing entity: GS1

Classification

Risk category: IVDR Class B
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 die In-vitro-Diagnostik. Der RIDASCREEN® Calprotectin Test ist ein manueller Enzymimmunoassay zum quantitativen Nachweis von Calprotectin in unbehandelten humanen Stuhlproben. Der RIDASCREEN® Calprotectin Test dient der Unterstützung bei der Diagnose von Patienten mit Verdacht auf chronisch-entzündliche Darmerkrankungen (CED), insbesondere Morbus Crohn (MC) und Colitis ulcerosa (CU), sowie zusammen mit anderen klinischen Biomarkern zur Unterscheidung von CED und Reizdarmsyndrom. Darüber hinaus kann der Test auch als Hilfsmittel zum Monitoring bei der Therapieüberwachung von CED verwendet werden. Die Testergebnisse sollten nicht als alleinige Grundlage für die Diagnosestellung herangezogen werden. Das Produkt ist für die professionelle Anwendung vorgesehen.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102019009CALPROTECTIN

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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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.