Fujirebio Europe

Address:TECHNOLOGIEPARK 6,GHENT Oost-Vlaanderen,BE

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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) (2) Slide Stainer, Automated (KPA) (2)

Premarket Exempt

Yes

Clear

TENDIGO - 05414470804122 Catalog Number :

Device Description : Instrument

Device Class : 1

Duns Number: 297346645

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : Yes

Device Count : 1

TENDIGO Disposable Trays - 05414470804214 Catalog Number :

Device Description : Disposable Trays 5 trays per base unit

Device Class : 1

Duns Number: 297346645

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : No

Device Count : 1

Auto-LiPA 48 - 05414470806287 Catalog Number :

Device Description : Instrument

Device Class : 1

Duns Number: 297346645

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : Yes

Device Count : 1

Auto-LIA 48 - 05414470806294 Catalog Number :

Device Description : Instrument

Device Class : 1

Duns Number: 297346645

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : Yes

Device Count : 1

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