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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

TZ8805 — IVDR Class A IVDR by R-Biopharm AG

MD Atlas
R-Biopharm AG

EUDAMED last updated this device on Nov 27, 2024

TZ8805

4049095TZ8805000065

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: 04049095200021
Reference / catalog number: TZ8805

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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: 04049095200021
Basic UDI-DI: 4049095TZ8805000065
Reference / catalog number: TZ8805
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 RIDA® TB Tubes are sterile blood collection tubes. They are intended for venous blood collection of human whole blood and subsequent Mycobacterium tuberculosis-specific induction of IP-10 in individuals with suspected M. tuberculosis infection (including disease). They are IVD specimen containers for the RIDASCREEN® TB (TC8806) or the RIDA®QUICK TB (TN8802). The RIDA® TB Tubes consist of a set of three blood collection tubes (negative control, positive control, test) per person to be tested. 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)

W050101010201BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification