BIRR Biosciences BV

Certificate BE25/00000073

Rev. 2Supplemented

Valid until: Mar 21, 2030

Certificate BE25/00000073 is a valid Quality management system issued to BIRR Biosciences BV and registered in EUDAMED. Valid until March 21, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: BE25/00000073
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1639BE25/000000732

Validity

Issued: Nov 17, 2025
Valid from: Nov 17, 2025
Valid until: Mar 21, 2030

Notified body

Notified body: SGS Belgium NV
Notified body SRN: 1639
Notified body country: Belgium

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: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Supplemented
Supplemented

Supersedes

BE25/00000073Quality management systemIssuedMar 21, 2025 → Mar 21, 2030

Scope coverage

Class IIa16

16 scopes

MDN1212, MDS1005
Class IIa
Sterile ICSI dish: ART Dish preparing and culturing gametes or embryos for use in assisted reproduction techniques (ART)
Class IIa
Sterile Semen Collection Container
Class IIa
Sterile Dropping Pipette
Class IIa
Sterile Microvial PP 1.8 mL
Class IIa
Sterile Conical Tube
Class IIa
Sterile Round Bottom Tube
Class IIa
Sterile Serological Pipette
Class IIa
Sterile 5-Well Dish and 6-Well Dish
Class IIa
Sterile 16-Well Dish
Class IIa
Sterile Culture Dish 35 mm Time Lapse
Class IIa
Sterile Culture Dish 60 mm
Class IIa
Sterile Culture Dish 90 mm
Class IIa
Sterile Center Well Dish
Class IIa
Sterile 4+8 Well Dish
Class IIa
Sterile Culture Dish 35 mm
Class IIa

Documents

LanguagesEN