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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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Vitrolife Sweden AB

Certificate 10000500631-PA-NoMA-SVK

Rev. 3Issued
Valid until
Sep 5, 2027

Certificate 10000500631-PA-NoMA-SVK is a valid Quality management system issued to Vitrolife Sweden AB and registered in EUDAMED. Valid until September 5, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number
10000500631-PA-NoMA-SVK
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
246010000500631-PA-NoMA-SVK3

Validity

Issued
Sep 6, 2022
Valid from
Sep 6, 2022
Valid until
Sep 5, 2027

Notified body

Notified body
DNV Product Assurance AS
Notified body SRN
2460
Notified body country
Norway

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
Yes
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 IIa11

11 scopes

  • Disposable Devices for IVF
    Class IIa
  • Labware
    Class IIa
  • Follicle Aspiration Set
    Class IIa
  • Gynaecological Needles
    Class IIa
  • Anaesthetic Needle
    Class IIa
  • Disposable Vitrification Device
    Class IIa
  • Sperm Collection Container
    Class IIa
  • Square Dishes
    Class IIa
  • Round Dishes
    Class IIa
  • Collection Tubes
    Class IIa
  • Centrifuge Tubes
    Class IIa

Documents

LanguagesEN

Manufacturer

Manufacturer
Vitrolife Sweden AB
Manufacturer SRN
SE-MF-000002389
Manufacturer country
Sweden