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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

GZ3013 — IVDR Class A IVDR by R-Biopharm AG

MD Atlas
R-Biopharm AG

EUDAMED last updated this device on May 23, 2022

GZ3013

4049095GZ30130000JR

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: 04049095070266
Reference / catalog number: GZ3013

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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: 04049095070266
Basic UDI-DI: 4049095GZ30130000JR
Reference / catalog number: GZ3013
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: 50
Additional product description: For in vitro diagnostic use. The RIDA®TUBE vials are unfilled stool collection tubes for the extraction of stool samples in the laboratory. The tests results should not be used as the sole basis for diagnosis. 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)

W050301020102SAMPLES ANALYSES, PLASTIC TUBES WITHOUT ADDITIVES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification