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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 10000500633-PA-NoMA-SVK

Rev. 5Issued
Valid until
Sep 6, 2027

Overview

Certificate number
10000500633-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
246010000500633-PA-NoMA-SVK5

Validity

Issued
Sep 6, 2022
Valid from
Sep 6, 2022
Valid until
Sep 6, 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
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 I9

9 scopes

  • Sterile medical devices for IVF procedures
    Class I
  • Labware
    Class I
  • Vacuum Pump Tubing
    Class I
  • Ultrasound Transmission Gel
    Class I
  • Ultrasound Transducer Cover
    Class I
  • Micromanipulation Pipettes: Biopsy Pipette Handling Pipette Hatching Pipette Holding Pipette ICSI Pipette Partial Zona Dissection (PZD) Pipette
    Class I
  • EmbryoCath Stylet
    Class I
  • EmbryoCath Embryo Transfer Catheter Labware
    Class I
  • Pasteur Pipette Serological Pipette
    Class I

Documents

LanguagesEN

Manufacturer

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