Health Express EU REPRESENTATIVE

PRODUCT OFFICIAL INFORMATION

Product namehealthExpress.

UMDNS code: 12461, «Mass Screening Systems».

Product code as per 93/42/EEC: MD 1302 Monitoring devices of vital physiological parameters.

Classification: class 2а as per Appendix IX of Directive 93/42/EEC, rule 10; class II type CF as per IEC 60601-1; group 1, class B as per CISPR 11; IPX0 as per IEC 60529.

Conformance to: European Directives 93/42/EEC (MDD), 2011/65/EU (RoHS 2), 2002/96/EC (WEEE)

Certificates: MD 574161 (DIN EN ISO 13485:2012)

Manufacturer: Medical Computer Systems Ltd.

ADDRESS: Passage 4922, 4-2, Zelenograd, Moscow, 124460, Russia.

PHONE\FAX: +7 495 913 31 94 \ +7 495 913 31 95.

E-mail: mks (at) mks.ru

Website: www.mks.ru

Authorized European Representative:

BIOPOWER TECHNOLOGIES (EUROPE) Ltd.

Address: Coliemore House, Coliemore Road, Dalkey, Co. Dublin A96 A8D5, Ireland

Tel.:+353 89 988 2873

Email: metcap26( at) gmail.com

Internet: www.myheartscan.eu

Рerforms duties from 2021-01-01

Notified certification body: BSI Group The Netherlands B.V., Say Building, John M. Keynesplein 9,

1066 EP Amsterdam, notified body number 2797

Authorized UK Representative:

MYHEARTSCAN Ltd.

ADDRESS:

Bluecube House, Blackhill Drive, Wolverton Mill, Milton Keynes, MK12 5TS United Kingdom.

PHONE: +44 7841 163693.

E-mail:  pm (at) myheartscan.co.uk

Notified certification body:

BSI, Kitemark Court, Davy Avenue, Knowhill, Milton Keynes MK5 8PP, United Kingdom, identification number 0086