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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

ZN1004 — IVDR Class A IVDR by R-Biopharm AG

MD Atlas
R-Biopharm AG

EUDAMED last updated this device on May 24, 2022

ZN1004

4049095ZN10040000S4

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: 04049095260032
Reference / catalog number: ZN1004

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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.

CW999
For warnings and precautions see IFU

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: 04049095260032
Basic UDI-DI: 4049095ZN10040000S4
Reference / catalog number: ZN1004
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: 25
Additional product description: For in-vitro diagnostic use. The RIDA®QUICK Rotavirus/Adenovirus Sample diluent is intended for the dilution of untreated human stool samples in people with symptoms of gastroenteritis who are tested with the RIDA®QUICK Rotavirus (N0903) or RIDA®QUICK Rotavirus/Adenovirus Combi (N1003) rapid 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)

W01050499VIROLOGY REAGENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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