BACTEROMIC SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

Certificate EU-QMS-FI-05877-800024-2026

Rev. 1Issued

Valid until: Feb 20, 2031

Certificate EU-QMS-FI-05877-800024-2026 is a valid Quality management system issued to BACTEROMIC SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ and registered in EUDAMED. Valid until February 20, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: EU-QMS-FI-05877-800024-2026
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 3018EU-QMS-FI-05877-800024-20261

Validity

Issued: Feb 20, 2026
Valid from: Feb 20, 2026
Valid until: Feb 20, 2031

Manufacturer

Manufacturer: BACTEROMIC SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
Manufacturer SRN: PL-MF-000040114
Manufacturer country: Poland

Notified body

Notified body: Sertio Oy
Notified body SRN: 3018
Notified body country: Finland

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable: —
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class B1

1 scope

IVR 0505 Devices intended to be used to grow / isolate / identify and handle infectious agents
IVDR Class B

Documents

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