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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

CHROMagar ESBL/CHROMagar KPC — IVDR Class A IVDR

MD Atlas
GRASO Zenon Sobiecki

EUDAMED last updated this device on Nov 27, 2023

CHROMagar ESBL/CHROMagar KPC

590470802068PD90QB

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: GRASO Zenon Sobiecki
UDI-DI code: 05904708004870
Reference / catalog number: 202068

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View device family (Basic UDI)

Manufacturer information

Organization name: GRASO Zenon Sobiecki
SRN: PL-MF-000022437
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
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Poland; available across 1 country total.

Placed on the market in Poland; per-country availability dates not published.

Device identification

Trade name: CHROMagar ESBL/CHROMagar KPC
UDI-DI code: 05904708004870
Basic UDI-DI: 590470802068PD90QB
Reference / catalog number: 202068
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: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0104010407BI-PLATES - INCLUDING NON-CHROMOGENIC & CHROMOGENIC MEDIA COMBINATION
W0104010404CHROMOGENIC RESISTANCE MARKER MEDIA (PLATES) - MRSA, VRE, ESBL …

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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