HYGIENX DOO BEOGRAD-RAKOVICA

Certificate EU-QA-FI-00219-800014-2025

Rev. 1Issued

Valid until: Nov 4, 2030

Certificate EU-QA-FI-00219-800014-2025 is a valid Production quality assurance issued to HYGIENX DOO BEOGRAD-RAKOVICA and registered in EUDAMED. Valid until November 4, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: EU-QA-FI-00219-800014-2025
Certificate type: Production quality assurance
Certificate status: Issued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 3018EU-QA-FI-00219-800014-20251

Validity

Issued: Nov 4, 2025
Valid from: Nov 4, 2025
Valid until: Nov 4, 2030

Manufacturer

Manufacturer: HYGIENX DOO BEOGRAD-RAKOVICA
Manufacturer SRN: RS-MF-000048020
Manufacturer country: Serbia

Notified body

Notified body
Notified body SRN: 3018
Notified body country: Finland

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
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

History

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class A1

1 scope

Sterile vacuum blood collection tubes with or without additives.
IVDR Class A

Documents

LanguagesEN