Cancelled Presafe Certificates

List of cancelled DS/EN 13485:2016 and DS/EN ISO 9001:2015 certificates.


Firma    Standard
Scope  Certifikat  Udløbsdato 

Actim OY
Klovinpellontie 3
02180 Espoo
Finland

 

13485:2016

The design and development, manufacture, distribution and service, of in-vitro diagnostic analyzers, in-vitro diagnostic test kits, controls and reagents used in diagnosis and screening of pregency, disease status, and endocrine disorders, including near patient in-vitro diagnostic devices

DGM-928

2023-11-03

Cimpax ApS
Lille Pilevang 4
3550 Slangerup
Denmark




 

13485:2016









Design, manufacture and distribution of instruments and accessories for laparoscopy, of instrument and accessories for
electrosurgery, and of catheters and accessories for delivery of anesthetics

DGM-681





 





2022-11-18









Grouleff-DK ApS
Korshøjvej 2A
Virklund
8600 Silkeborg
Denmark

 

 13485:2016

 Design and production of customer specific examination tables

DGM-834

 2023-05-22

Origio a/s
Knardrupvej 2
2760 Måløv
Denmark

 

 13485:2016

Design, development, manufacture, final testing and distribution of storage devices, cell culture products, needles and catheters for use in assisted reproductive technology (ART) procedures

 DGM-510

 2022-12-30

OY Medix Biochemica Ab
Klovinpellontie 3
02180 Espoo
Finland

 

13485:2016

The design and development, manufacture and distribution of reagents used in in-vitro diagnostic devices and controls

DGM-543

2023-11-03

Price Invena ApS
Kronprinsessegade 36, 2 floor
1306 Copenhagen K
Denmark

 

 13485:2016

 Manufacturing and testing of umbilical cord cutters

 DGM-854

2022-02-04 

Visiopharm A/S
Agern Allé 24
2970 Hørsholm
Denmark

 

13485:2016

Design, development, manufacture, installation and service of in vitro diagnostic pathology software

DGM-913

2021-12-28