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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-520014 — IVDR Class B IVDR by BACTEROMIC SPÓŁKA Z…

MD Atlas
BACTEROMIC SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

EUDAMED last updated this device on May 25, 2026

BQS-520014

59047268494PanelFASTI32

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: 05904726849415
Reference / catalog number: BQS-520014

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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

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

CW007
EUDAMED did not publish a description for this code.
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.

Country	On market since	Until
PolandPrimary placement	May 25, 2026	May 25, 2099

Device identification

Trade name: not provided
UDI-DI code: 05904726849415
Basic UDI-DI: 59047268494PanelFASTI32
Reference / catalog number: BQS-520014
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)05904726849415

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

W0104080113OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)

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