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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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"Biovico" Spółka z ograniczoną odpowiedzialnością

Certificate 1434-MDR-035/2025

Rev. 1/ 16.12.2025/ S/045/BM/2023Issued
Valid until
Dec 15, 2030

Overview

Certificate number
1434-MDR-035/2025
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
14341434-MDR-035/20251/ 16.12.2025/ S/045/BM/2023

Validity

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

Manufacturer

Manufacturer
"Biovico" Spółka z ograniczoną odpowiedzialnością
Manufacturer SRN
PL-MF-000010559
Manufacturer country
Poland

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
Yes
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 III4

4 scopes

  • V9099
    Class III
  • Flavya™ Light
    Class III
  • Flavya™ Medium
    Class III
  • Flavya™ Excellence
    Class III

Documents

LanguagesENPL