Cancelled Presafe Certificates

List of cancelled DS/EN ISO 13485:2003, 13485:2012, DS/EN ISO 9001:2000 and DS/EN ISO 9001:2008 certificates.


Firma  Standard Scope  Certifikat  Udløbsdato 

Bernafon Högerate Gmbh
Nunsdorfer Ring 14
12277 Berlin
Germany 


9001:2008  Design and servicing of BTE hearing aids, production, distribution and servicing of ITE hearing aids and production and distribution of ear molds  DGM-434  2019-01-19

Bernafon LLC
580 Howard Avenue, Somerset
08873 New Jersey
USA

13485:2012 Manufacture, sales, distribution and servicing of air conduction hearing aids and faceplates including accessories and programming systems DGM-805 2019-03-31

Biomediq A/S
Fruebjergvej 3
2100 København Ø
Denmark

9001:2008 &13485:2012

Design and development of software for medical image quantification purposes

DGM-870

2018-10-23

BioTelemetry Technology ApS
Venlighedsvej 4
2970 Hørsholm
Denmark

13485:2012

Design, development, manufacture and sales of medical devices for monitoring, measuring, and recording vital and non-vital physiological parameters

DGM-888

2018-12-21

Codan Steritex ApS
Højvangen 6
3060 Espergærde
Denmark

 

13485:2012

Manufacture of singe use continence care products

DGM-793

2018-12-16

Delta Dansk Elektronik, Lys & Akustik
Venlighedsvej 4
2970 Hørsholm
Denmark

13485:2012

Design, development, manufacture and sales of medical devices for monitoring, measuring & recording vital and non-vital physiological parameters

DGM-796

2018-12-21

FH Service
Falen 18B
5000 Odense C
Denmark

13485:2012

Production and servicing of therapeutic muscle stimulators

DGM-867

2018-08-12

Nanovi A/S
Diplomvej 373N
2800 Lyngby
Denmark

13485:2012

Design, manufacture and distributing of injectable liquid tissue marker

DGM-880

2019-03-18

Pharma Source BV
Reduitlaan 33
4814 BC Breda
The Netherlands

13485:2012

Design, manufacture and final test of medical devices for self care treatment within nail fungus, warts, mouth ulcers, hay fever and vaginal gel

DGM-849

2018-06-19

Philips BioCell A/S
Gydevang 42
3450 Allerød
Danmark

13485:2012 Design, production and service of electro-opticaldevices for the in vitro medical diagnostic industry DGM-669 2019-01-20

Statens Serum Institut
Artillerivej 5
2300 København S
Danmark

9001&13485 Udvikling, produktion og salg af in vitro-diagnostika og blodprodukter fra dyr DGM-645 2018-09-15

Wondermed (PTY) Ltd.            
Unit 22c Waverley Business Park Kotzee Road Mowbray, 7700 South Africa

13485:2003 Production, servicing and installation of wound management systems DGM-707 2019-03-31