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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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MIM Fertility Sp. z o.o.

Certificate 1434-MDR-010/2024

Rev. 1 / 01.08.2024 / S/050/BM/2023Issued
Valid until
Jul 31, 2029

Certificate 1434-MDR-010/2024 is a valid Quality management system issued to MIM Fertility Sp. z o.o. and registered in EUDAMED. Valid until July 31, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number
1434-MDR-010/2024
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
14341434-MDR-010/20241 / 01.08.2024 / S/050/BM/2023

Validity

Issued
Aug 1, 2024
Valid from
Aug 1, 2024
Valid until
Jul 31, 2029

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
No
Human tissues
No
Animal tissues
No
In vitro diagnostics
No
Initial registration
Yes
New device
No
Discard allowed
No
SSCP enabled
Yes
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 IIa2

2 scopes

  • Z12080292 - GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS- MEDICAL DEVICE SOFTWARE
    Class IIa
  • FOLLISCAN
    Class IIa

Manufacturer

Manufacturer
MIM Fertility Sp. z o.o.
Manufacturer SRN
PL-MF-000030821
Manufacturer country
Poland

Documents

LanguagesENPL