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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

MacConkey Agar No.3 (55 mm) — IVDR Class A IVDR by Biolab Zrt

MD Atlas
Biolab Zrt

EUDAMED last updated this device on Aug 15, 2023

MacConkey Agar No.3 (55 mm)

5996650SZEDI5000X4

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Biolab Zrt
UDI-DI code: 05996650001359
Reference / catalog number: MCA50055

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Manufacturer information

Organization name: Biolab Zrt
SRN: HU-MF-000024675
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.

Market distribution

Primary placement in Hungary; available across 1 country total.

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

Device identification

Trade name: MacConkey Agar No.3 (55 mm)
UDI-DI code: 05996650001359
Basic UDI-DI: 5996650SZEDI5000X4
Reference / catalog number: MCA50055
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: A selective and differential medium for the detection of coliforms and enteric pathogens.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0104010405NON-CHROMOGENIC MEDIA (PLATES)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification