Cancelled Presafe Certificates

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


Firma  Standard
Scope  Certifikat  Udløbsdato 

Medicologic A/S
Arne Jacobsens Allé 15-17
2300 Copenhagen S
Denmark

13485:2016

Contract design and Development services related to consumables for the Medical Device Industry and the In Vitro Diagnostic Device Industry

DGM-782

2021-05-18

N.V. Organon
Kloosterstraat 6
5349 AB, OSS
The Netherlands

13485:2016

Post marketing surveillance of neuromusclar transmission monitors and handling of accessories and spae parts for neuromuscular transmission monitors

DGM-865

2021-08-21

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

Bernafon AG
Morgenstrasse 131
3018 Bern
Switzerland

13485:2016

Development, production, marketing, sales and service of audiological solutions for better hearing

DGM-650

2021-09-27

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

Ellipse A/S
Agern Allé 11
2970 Hørsholm
Denmark


 13485:2016

 Decvelopment, design, production and service of IPL and Laser equipment for medical treatment

 DGM-459

 2020-08-14

Lehiso A/S
1Kongebakken 8
2765 Smørum
Denmark

13485:2016 Development and production of apps for hearing solutions DGM-884 2021-08-06

Oticon A/S
Kongebakken 9
2765 Smørum
Denmark

13485:2016 Development, production, sales and service of audiological solutions for better hearing DGM-640 2021-09-27

Oticon A/S
DGS Denmark A/S
Tempovej 15
2750 Ballerup
Denmark

13485:2016 Development, production, sales and service of audiological solutions for better hearing DGM-640 2021-09-27

Oticon A/S
DGS Denmark A/S
Tilstedvej 73
7700 Thisted
Denmark

13485:2016 Development, production, sales and service of audiological solutions for better hearing DGM-640 2021-09-27

Oticon A/S
DGS Poland Sp. zo. o.
ul. Lubieszynska 59 Mierzyn, 
72-006 Szczecin
Poland

13485:2016 Development, production, sales and service of audiological solutions for better hearing DGM-640 2021-09-27

Oticon A/S
DGS Poland Sp. zo. o.
ul. Lubieszynska 42 Mierzyn, 
72-006 Szczecin
Poland

13485:2016 Development, production, sales and service of audiological solutions for better hearing DGM-640 2021-09-27

Oticon A/S
DGS Business Services Sp.z.o.o.
ul. Malczewskiego 26
71-612 Szczecin
Poland

13485:2016 Development, production, sales and service of audiological solutions for better hearing DGM-640 2021-09-27

SBO Hearing A/S
Kongebakken 9
2765 Smørum
Denmark

13485:2016 Development, production, marketing, sales and service of audiologic solutions for better hearing DGM-914 2021-09-27

Sonic Innovations, Inc. 
2501 Cottontail Lane

NJ 08873,
USA

13485:2016 Development, production, marketing, sales and service of audiological solutions for better hearing DGM-472 2021-09-27