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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 (ENTEROCOCCUS GROWTH)/… — IVDR Class A IVDR

MD Atlas
Sundial Co. Ltd

EUDAMED last updated this device on Mar 31, 2026

MACCONKEY (ENTEROCOCCUS GROWTH)/ UTI CHROM AGAR

5298004040183YA

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Sundial Co. Ltd
UDI-DI code: 05298004040183
Reference / catalog number: SUN45400

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Manufacturer information

Organization name: Sundial Co. Ltd
SRN: CY-MF-000023765
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

4 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Cyprus; available across 1 country total.

Country	On market since	Until
CyprusPrimary placement	Aug 18, 2015	Still on market

Device identification

Trade name: MACCONKEY (ENTEROCOCCUS GROWTH)/ UTI CHROM AGAR
UDI-DI code: 05298004040183
Basic UDI-DI: 5298004040183YA
Reference / catalog number: SUN45400
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.

EMDN nomenclature code(s)

W0104010407BI-PLATES - INCLUDING NON-CHROMOGENIC & CHROMOGENIC MEDIA COMBINATION

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification