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Organization name
UDI-DI code
Reference / catalog number

733023 — IVDD — General IVDD by Mast Diagnostica GmbH

MD Atlas
Mast Diagnostica GmbH

EUDAMED last updated this device on Mar 19, 2024

733023

B-04250729700330

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Mast Diagnostica GmbH
UDI-DI code: 04250729700330
Reference / catalog number: 733023

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Manufacturer information

Organization name: Mast Diagnostica GmbH
SRN: DE-MF-000005298
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW266
Components of human origin are given in IFU

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Mar 22, 2004	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04250729700330
Basic UDI-DI: B-04250729700330
Reference / catalog number: 733023
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: The MASTAZYME™ ENA Screen 7 is an enzyme immunoassay for the qualitative detection and screening of specific autoantibodies to SS-A, SS-B, Sm, Sm/RNP, Scl-70, Jo-1 and Centromer in human serum and plasma used in the analysis of autoimmune diseases. The assay is suitable for manual or automated use on open EIA processor systems and is intended for professional in vitro diagnostic use only. All laboratory test results should be interpreted in conjunction with other clinical data. The clinical judgement and further tests have to be taken into account.
Additional information URL: https://www.mast-group.com/de/products/autoimmune-diagnostics/autoimmune-elisa-ena/733023/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102100102ENA SCREENING

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.