Scinus Cell Expansion Netherlands B.V.

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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

System, Suspension, Cell Culture (KJF) (5)

Premarket Exempt

Yes

Clear

Scinus Cell Expansion System - 08720299213609 Catalog Number :

Device Description : The SCINUS consists of a cabinet that encloses a temperature-controlled environm

Device Class : 1

Duns Number: 493047487

Premarket Exempt : Yes

Product Code : KJF

Prescription Use : No

Device Count : 1

Adherent Bag - 08720299213616 Catalog Number :

Device Description : For the adherent cell culture inside the SCINUS the Adherent Bag is used. ThisAd

Device Class : 1

Duns Number: 493047487

Premarket Exempt : Yes

Product Code : KJF

Prescription Use : No

Device Count : 1

1L Bottle - 08720299213623 Catalog Number :

Device Description : This bottle can be used for the addition and removal of liquids to/from e.g. the

Device Class : 1

Duns Number: 493047487

Premarket Exempt : Yes

Product Code : KJF

Prescription Use : No

Device Count : 1

2L Buffer Bottle - 08720299213630 Catalog Number :

Device Description : This bottle can be used for slowly medium refreshment of the e.g. Adherent Bag.

Device Class : 1

Duns Number: 493047487

Premarket Exempt : Yes

Product Code : KJF

Prescription Use : No

Device Count : 1

2L MC Bottle - 08720299213647 Catalog Number :

Device Description : This bottle can be used for the hydration of microcarriers and to reconstitute

Device Class : 1

Duns Number: 493047487

Premarket Exempt : Yes

Product Code : KJF

Prescription Use : No

Device Count : 1

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