FAQ

Does Mennen Medical have quality certificate?

Mennen Medical has a CMDCAS recognized, ISO 13485:2003

(certified by Amtac certification services)

Which of Mennen Medical devices have CE certificate?

All Mennen Medical devices have 0473 CE certificate.

Does Mennen Medical comply with Environment management requirement?

Mennen medical is Certificated according to ISO 14001 standard.

What is the regulatory classification of Mennen Medical products?

Device FDA CE Health Canada
VitaLogik

II

II b

3

Mentor X7

II

II b

3

Ensemble

III

II b

3

Horizon XVu

II

II b

3

EMS XL

II

II b

3

Which Mennen Medical monitors have Health Canada license

See below a table of Health Canada License numbers
Note: refer to Health Canada site for part numbers details

http://webprod5.hc-sc.gc.ca/mdll-limh/start-debuter.do?lang=eng

Licence No. Device name
81376 VITALOGIK PATIENT MONITOR

VITALOGIK 4000

VITALOGIK 4500

VITALOGIK 6000

94156 CEREBRALOGIK
3401 ENSEMBLE CENTRAL STATION MONITOR
3732 ENSEMBLE CENTRAL STATION MONITOR
80957 HORIZON XVU
3414 HORIZON SE (CATHLAB)
68979 HORIZON ANGIO CATHLAB SYSTEM
81081 EMS-XL, CARDIAC ELECTROPHYSIOLOGY SYSTEM, 32 / 64  CHANNELS, CONSOLE