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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

340021 — IVDR Class A IVDR by DELTAROM SRL

MD Atlas
DELTAROM SRL

EUDAMED last updated this device on Jul 28, 2025

340021

594054038AGARSABOURAU12ZT

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: DELTAROM SRL
UDI-DI code: 05940540380031
Reference / catalog number: 340021

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View device family (Basic UDI)

Manufacturer information

Organization name: DELTAROM SRL
SRN: RO-MF-000035924
Manufacturer status: Active

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340027594054038AGARSABOURAUD23LOn the market 340025594054038AGARSABOURAUDC4LOn the market 3400225594054038AGARSABOURAUD13JOn the market 340035594054038AGARmENTEROCOCX3On the market 34003255594054038AGARmENTEROCO1VZOn the market

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Romania; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05940540380031
Basic UDI-DI: 594054038AGARSABOURAU12ZT
Reference / catalog number: 340021
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: Mediu de cultura
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.

W0104010405NON-CHROMOGENIC MEDIA (PLATES)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.