COPAN WASP SRL

Address:Via Achille Grandi, 32,Brescia Lombardy,IT

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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

Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry (QQV) (3) Device, Microtiter Diluting/Dispensing (JTC) (3) Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates (QBN) (3) Station, Pipetting And Diluting, For Clinical Use (JQW) (2) Calculator/Data Processing Module, For Clinical Use (JQP) (1)

Premarket Exempt

No Yes

Clear

Pipettor Module - 58050148218277 Catalog Number : W086-090

Device Description : Pipettor Module

Device Class : 1

Duns Number: 434263590

Premarket Exempt : Yes

Product Code : JTC

Prescription Use : Yes

Device Count : 1

Slide Prep Evo™ - 58050148218970 Catalog Number : W086-40N

Device Description : Slide Prep Evo™

Device Class : 1

Duns Number: 434263590

Premarket Exempt : Yes

Product Code : JTC

Prescription Use : Yes

Device Count : 1

WASP-FLO™ - 58052870811115 Catalog Number : W091

Device Description : WASP-FLO™

Device Class : 1

Duns Number: 434263590

Premarket Exempt : Yes

Product Code : JQP

Prescription Use : Yes

Device Count : 1

Collaborative Station - 58052870813669 Catalog Number : W092

Device Description : Collaborative Station

Device Class : 1

Duns Number: 434263590

Premarket Exempt : Yes

Product Code : JTC

Prescription Use : Yes

Device Count : 1

UniVerse® - 58052870815038 Catalog Number : W093

Device Description : UniVerse®

Device Class : 1

Duns Number: 434263590

Premarket Exempt : Yes

Product Code : JQW

Prescription Use : Yes

Device Count : 1

Colibrí™ System - 58052870816202 Catalog Number : W090.US

Device Description : Colibrí™ System

Device Class : 2

Duns Number: 434263590

Premarket Exempt : No

Product Code : QQV, QBN

Prescription Use : Yes

Device Count : 1

Colibrí™ Vision System - 58052870818428 Catalog Number : W090-02

Device Description : Colibrí™ Vision System

Device Class : 2

Duns Number: 434263590

Premarket Exempt : No

Product Code : QQV, QBN

Prescription Use : Yes

Device Count : 1

Colibrí™ Preparation Station - 58052870818435 Catalog Number : W090

Device Description : Colibrí™ Preparation Station

Device Class : 2

Duns Number: 434263590

Premarket Exempt : No

Product Code : QQV, QBN

Prescription Use : Yes

Device Count : 1

External Loader - Turn Table - 58052870818923 Catalog Number : W093-10

Device Description : External Loader - Turn Table

Device Class : 1

Duns Number: 434263590

Premarket Exempt : Yes

Product Code : JQW

Prescription Use : Yes

Device Count : 1

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