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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

BQS-520010 — IVDR Class B IVDR by BACTEROMIC SPÓŁKA Z…

MD Atlas
BACTEROMIC SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

EUDAMED last updated this device on Feb 24, 2026

BQS-520010

59047268494ISW-2.0UM

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: BACTEROMIC SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
UDI-DI code: 05904726849477
Reference / catalog number: BQS-520010

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View device family (Basic UDI)

Manufacturer information

Organization name: BACTEROMIC SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
SRN: PL-MF-000040114
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Feb 24, 2026	Dec 31, 2070

Device identification

Trade name: not provided
UDI-DI code: 05904726849477
Basic UDI-DI: 59047268494ISW-2.0UM
Reference / catalog number: BQS-520010
Issuing entity: GS1

Classification

Risk category: IVDR Class B
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

UDI-DI DataMatrix

Encoded

(01)05904726849477

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EMDN nomenclature code(s)

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

W0203010192ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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Certificates

Certificate health across this manufacturer's portfolio.

EU-QMS-FI-05877-800024-2026Issued
Quality management systemNotified body: 3018Expiry: Feb 20, 2031