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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

GK2020-EN — IVDR Class A IVDR by MVZ Medizinische Labore…

MD Atlas
MVZ Medizinische Labore Dessau Kassel GmbH

EUDAMED last updated this device on Feb 29, 2024

GK2020-EN

426240865GK206H

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: MVZ Medizinische Labore Dessau Kassel GmbH
UDI-DI code: 04262408650034
Reference / catalog number: GK2020-EN

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Manufacturer information

Organization name: MVZ Medizinische Labore Dessau Kassel GmbH
SRN: DE-MF-000033982
Manufacturer status: Active

Critical warnings

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

CW265
see hazard statements on packaging

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: 04262408650034
Basic UDI-DI: 426240865GK206H
Reference / catalog number: GK2020-EN
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: 20
Additional product description: 20 micro vials with sample transport medium
Additional information URL: https://www.labor-dessau-kassel.de/unser-labor/qualitaetsmanagement/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A99DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER

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.