"Biovico" Spółka z ograniczoną odpowiedzialnością

Certificate 1434-MDR-031/2025

Rev. 1/16.12.2025/S/043/BM/2023Issued

Valid until: Dec 15, 2030

Certificate 1434-MDR-031/2025 is a valid Quality management system issued to "Biovico" Spółka z ograniczoną odpowiedzialnością and registered in EUDAMED. Valid until December 15, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 1434-MDR-031/2025
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 14341434-MDR-031/20251/16.12.2025/S/043/BM/2023

Validity

Issued: Dec 16, 2025
Valid from: Dec 16, 2025
Valid until: Dec 15, 2030

Notified body

Notified body: POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Notified body SRN: 1434
Notified body country: Poland

Covered devices

No specific devices are listed for this certificate.

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III5

5 scopes

P900402
Class III
Biolevox™ HA
Class III
Biolevox™ HA mini
Class III
Biolevox™ HA one
Class III
Monoshot™ HA
Class III