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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

3019V01-VK — IVDR Class A IVDR by R-Biopharm AG

MD Atlas
R-Biopharm AG

EUDAMED last updated this device on Dec 12, 2024

3019V01-VK

40490953019V01VK0VL

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: 04049095000010
Reference / catalog number: 3019V01-VK

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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.

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 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: 04049095000010
Basic UDI-DI: 40490953019V01VK0VL
Reference / catalog number: 3019V01-VK
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: For in vitro diagnostic use. The RIDASCREEN® Substrate (3019V01-VK) is as substrate intented for use with the RIDASCREEN® Clostridium perfringens Enterotoxin (C0601), RIDASCREEN® Clostridium difficile GDH (C0701), RIDASCREEN® Clostridium difficile Toxin A/B (C0801), RIDASCREEN® Rotavirus (C0901), RIDASCREEN® Adenovirus (C1001), RIDASCREEN® Giardia (C1101), RIDASCREEN® Cryptosporidium (C1201), RIDASCREEN® Astrovirus (C1301), RIDASCREEN® Norovirus 3rd Generation (C1401), RIDASCREEN® Entamoeba (C1701), RIDASCREEN® Verotoxin (C2201), RIDASCREEN® Helicobacter (C2302), RIDASCREEN® Campylobacter (C2401), RIDASCREEN® Legionella (C8001) and RIDASCREEN® TB (TC8806) test. The product is intended for professional use.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105900201BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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