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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

977564 — IVDR Class A IVDR by Greiner Bio-One GmbH

MD Atlas
Greiner Bio-One GmbH

EUDAMED last updated this device on Apr 10, 2024

977564

4039943001359L

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Greiner Bio-One GmbH
UDI-DI code: 34039943001352
Reference / catalog number: 977564

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Manufacturer information

Organization name: Greiner Bio-One GmbH
SRN: DE-MF-000032396
Manufacturer status: Active

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126280-2DG4039943002079LOn the market 3852784039943000619GOn the market 9775634039943001349JOn the market 97656840399430012199On the market 122263-TRI403994300177A4On the market

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.

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: 34039943001352
Basic UDI-DI: 4039943001359L
Reference / catalog number: 977564
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: 960
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W05020199SAMPLES TRANSPORT, CONTAINERS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification