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LA:GEMIDDELSTYRELSEN
DANISH MEDICINES AGENCY
Free Sales Certificate
The Danish Health and Medicines Authority hereby certifies that the medical devices
specified in the attached list are manufactured by:
Cardia International A/S
Hersegade 20
4000 Roskilde Denmark
Medical devices which are CE marked in conformity with Directive 98/79/EEC meet the
essential requirements for safety and performance. They may therefore be manufactured
and marketed in Denmark and exported without any approval from the Danish Health and
Medicines Authority.
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LA:GEM IDDELSTYRE LSEN
DANISH MEDICINES AGENCY
Valid from: 10 ,March 2021 Katrine Hagen Lema
Valid Until: 10 March 2023 Scientific Officer
Axel Heides Gade l T +45 44 88 95 95 [email protected]
DK-2300 K¢benhavn S F +45 44 88 95 99 www.medicinskudstyr.dk 1 (2)
Verify the authenticity of this document by checking that a multicoloured 3D GENUINE ORIGINAL hologram is present at the top right corner
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LJeGEMIDDELSTYRELSEN
DANISH MEDICINES AGENCY
Product name Catalog Number Number of tests per kit
CardiAid AED-Full Automatic CT0207RF 25
CardiAid AED-Semi Automatic CT0207RS 25
CardiAid Pro Biphasic Defibrillator Pro 25
CardiAid Pro+ Biphasic Defibrillator Pro+ 12
HemaVision®-7Q HV01-7Q 12
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HemaVision®-9 ;22N HV02-922N 25 �
HemaVision®-8;2 lN HV02-821N 25
HemaVision®-15;17N HV02-1517N 25 /A'-
HemaVision®-inv16N HV02-16N 25 � ,(/
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HemaVision®-5;12N HV02-512N 25
HemaVision®-1;19 HV03-119 25 �
HemaVision®-4;11
HemaVision®-8;21
HemaVision®-9;22
HV03-411
HV03-821
HV03-922 (
25
25
25
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HemaVision®-12;21 HV03-1221 >� 25
HemaVision®-15;17 HV03-1517 � � 25
HemaVision®-inv16 HV03-16 '� 25 ..
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HemaVision®-RM HV04-RM � -
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HemaVision®-7 Positive Controls HV05-7PC ,. � 1
HemaVision®-RMP HV06-RMP - -
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LA:GEMIDDELSTYRELSEN
DANISH MEDICINES AGENCY
2 (2)
Verify the authenticity of this document by checking that a multicoloured 3D GENUINE ORIGINAL hologram is present at the top right corner
