EC Declaration of Conformity (DoC)
We herewith declare that our products meet the provisions of all applicable EU Directives including the European Committee Council Directive 2014/53/EU on Radio Equipment and its harmonized standards. All supporting documentation are retained under the promises of the manufacturer.
Each Declaration of Conformity is valid in connection with the shipping inspection reports for the respective batch of produced devices. Model and Code are indicated on product rating label.
Blood pressure monitors
Product Code |
RS3 Intelli IT (HEM-6161T-D): DoC information |
RS3 Intelli IT (HEM-6161T-E): DoC information |
RS7 Intelli IT (HEM-6232T-D): DoC information |
RS7 Intelli IT (HEM-6232T-E): DoC information |
HEARTGUIDE (HEM-6411T-MAE): DoC information |
M300 Intelli IT (HEM-7143T1-D): DoC information |
M2 Intelli IT (HEM-7143T1-EBK): DoC information |
X2 Smart (HEM-7143T2-ESL): DoC information |
M2 Intelli IT+ (HEM-7146T2-EBK): DoC information |
X2 Smart+ (HEM-7146T2-ESL): DoC information |
M400 Intelli IT (HEM-7155T-D): DoC information |
M4 Intelli IT (HEM-7155T-EBK): DoC information |
X4 Smart (HEM-7155T-ESL): DoC information |
MIT5s (HEM-7280T-E): DoC information |
M700 Intelli IT (HEM-7322T-D): DoC information |
M7 Intelli IT (HEM-7322T-E): DoC information |
M500 Intelli IT (HEM-7361T-D): DoC information |
M7 Intelli IT (HEM-7361T-EBK): DoC information |
X7 Smart (HEM-7361T-ESL): DoC information |
EVOLV (HEM-7600T-E): DoC information |
HEM-9210T-E: DoC information |
Nightview (HEM-9601T-E3): DoC information |
M7 Intelli IT AFib (HEM-7380T1-EBK): DoC information |
X7 Smart AFib (HEM-7380T1-EOSL): DoC information |
M2+ Connect (HEM-7188T1-LE):DoC information |
X2+ Connect (HEM-7188T1-LEO): DoC information |
M4 Connect AFib (HEM-7196T1-FLE): DoC information |
X4 Connect AFib (HEM-7196T1-FLEO): DoC information |
Wheeze monitor
Product code |
WheezeScan (HWZ-1000T-E): DoC information |
Pain relievers (TENS)
Product code |
Avail (HV-F601T-E): DoC information |
Scales and body composition monitors
Product code |
VIVA (HBF-222T-EBK): DoC information |
HN300T2 Intelli IT Black (HN-300T2-EBK): DoC information |
HN300T2 Intelli IT Grey (HN-300T2-EGY): DoC information |
Blood saturation monitor
Product code |
P300 Intelli IT (HPO-300T): DoC information |
Electrocardiograms
Product code |
Complete (HEM-7530T-E3): DoC information |
HeartScan 6L (HCG-8060T-E): DoC information |