ELITechGroup B.V.

Address:VAN RENSSELAERWEG 4,SPANKEREN Gelderland,NL

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (JJE) (4) Device, Automated Sedimentation Rate (GKB) (3) Electrode, Ion Specific, Sodium (JGS) (2) Electrode, Ion Specific, Potassium (CEM) (1)

Premarket Exempt

No Yes

Clear

Viva-E® - 03661540600050 Catalog Number :

Device Class : 1

Duns Number: 494028946

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

V-Twin® - 03661540600180 Catalog Number :

Device Class : 1

Duns Number: 494028946

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Viva-Jr® - 03661540600210 Catalog Number :

Device Class : 1

Duns Number: 494028946

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Viva-ProE® - 03661540600357 Catalog Number :

Device Class : 1

Duns Number: 494028946

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Selectra - 03661540600395 Catalog Number : 6003-435

Device Class : 2

Duns Number: 494028946

Premarket Exempt : No

Product Code : JGS

Prescription Use : No

Device Count : 1

Selectra - 03661540600401 Catalog Number : 6003-436

Device Class : 2

Duns Number: 415733737

Premarket Exempt : No

Product Code : JGS

Prescription Use : No

Device Count : 1

Selectra - 03661540600418 Catalog Number : 6003-600

Device Class : 2

Duns Number: 494028946

Premarket Exempt : No

Product Code : CEM

Prescription Use : No

Device Count : 1

Excyte® - 03661540700064 Catalog Number :

Device Class : 1

Duns Number: 415733737

Premarket Exempt : Yes

Product Code : GKB

Prescription Use : No

Device Count : 1

Excyte® - 03661540700071 Catalog Number :

Device Class : 1

Duns Number: 415733737

Premarket Exempt : Yes

Product Code : GKB

Prescription Use : No

Device Count : 1

Excyte® - 03661540700118 Catalog Number :

Device Class : 1

Duns Number: 415733737

Premarket Exempt : Yes

Product Code : GKB

Prescription Use : No

Device Count : 1

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