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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

Atlas Brucella Antigen Kit with… — IVDD — General IVDD

MD Atlas
Atlas Medical GmbH

EUDAMED last updated this device on Jul 1, 2023

Atlas Brucella Antigen Kit with Controls, (5ml Brucella melitensis, 5ml Brucella abortus, 2x1.0 ml Controls)

B-04260658551439

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: 04260658551439
Reference / catalog number: 8.01.15.1.0010

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Manufacturer information

Organization name: Atlas Medical GmbH
SRN: DE-MF-000029961
Manufacturer status: Active

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: Atlas Brucella Antigen Kit with Controls, (5ml Brucella melitensis, 5ml Brucella abortus, 2x1.0 ml Controls)
UDI-DI code: 04260658551439
Basic UDI-DI: B-04260658551439
Reference / catalog number: 8.01.15.1.0010
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 Brucella Antigen Set is for the qualitative and semi-quantitative detection of Brucella agglutinins in Brucella infection.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105011701BRUCELLA

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.