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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

RPR Carbon Antigen Kit, 100 Tests… — IVDD — General IVDD

MD Atlas
Atlas Medical GmbH

EUDAMED last updated this device on Jul 22, 2023

RPR Carbon Antigen Kit, 100 Tests (2 ml Reagent, 2x0.5 ml Controls, White Glass slide, Stirring sticks).

B-04260658557455

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Atlas Medical GmbH
UDI-DI code: 04260658557455
Reference / catalog number: 8.00.18.2.0100

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Manufacturer information

Organization name: Atlas Medical GmbH
SRN: DE-MF-000029961
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
Read the instructions for use before using the kit

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: RPR Carbon Antigen Kit, 100 Tests (2 ml Reagent, 2x0.5 ml Controls, White Glass slide, Stirring sticks).
UDI-DI code: 04260658557455
Basic UDI-DI: B-04260658557455
Reference / catalog number: 8.00.18.2.0100
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Atlas RPR Carbon Antigen Kit is a manual rapid plasma reagin carbon test for the qualitative and semi-quantitative detection of non-treponemal antibodies against Syphilis in human serum and plasma to provide serological evidence of past/current Syphilis infections when proceeded by a positive treponemal test. Not to be used as a screening tool for blood or tissue donations.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105010399SYPHILIS REAGENTS OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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