Cancelled Presafe Certificates
List of cancelled DS/EN 13485:2016 and DS/EN ISO 9001:2015 certificates.
| Firma | Standard |
Scope | Certifikat | Udløbsdato | |
|
Actim OY |
|
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 |
|
13485:2016 |
Design, manufacture and distribution of instruments and accessories for laparoscopy, of instrument and accessories for |
DGM-681
|
2022-11-18 |
|
Elltec Co. Ltd |
|
13485:2016 |
Design, development, production and servicing of blood warmers |
DGM-559 |
2021-12-14 |
|
Grouleff-DK ApS |
|
13485:2016 |
Design and production of customer specific examination tables |
DGM-834 |
2023-05-22 |
|
Origio a/s |
|
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 |
|
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 |
|
13485:2016 |
Manufacturing and testing of umbilical cord cutters |
DGM-854 |
2022-02-04 |
|
SP Medical A/S |
|
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 |
|
13485:2016 |
Design, development, manufacture, installation and service of in vitro diagnostic pathology software |
DGM-913 |
2021-12-28 |