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









 Elltec Co. Ltd
Shirakawa No. 6, Bldg. 2-18-5, Nishiki
Naka-ku, Nagoya
Japan

 

 13485:2016

 Design, development, production and servicing of blood warmers

 DGM-559

 2021-12-14

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 

SP Medical A/S
Møllevej 1
4653 Karise
Denmark

 

13485:2016

Design and development, production, trade and distribution of medical devices made of metal, alloy, and plastics. Production, filling, assembly, packing, coating and decoration of injection molded plastic and metal parts to be used for medical devices

DGM-728

2021-11-06

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