REGEN LAB SA

Address:EN BUDRON B2,LE MONT-SUR-LAUSANNE Vaud,CH

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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

Bottle, Roller, Tissue Culture (KJC) (2) Needle, Hypodermic, Single Lumen (FMI) (1) Platelet And Plasma Separator For Bone Graft Handling (ORG) (1) Syringe, Piston (FMF) (1)

Premarket Exempt

No Yes

Clear

RegenET - 07640138981364 Catalog Number :

Device Class : 1

Duns Number: 482206518

Premarket Exempt : Yes

Product Code : KJC

Prescription Use : Yes

Device Count : 1

Accessory Set - 07640138981432 Catalog Number :

Device Class :

Duns Number: 482206518

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

Accessory Set - 07640138981449 Catalog Number :

Device Class :

Duns Number: 482206518

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

RegenET - 07640138981487 Catalog Number :

Device Class : 1

Duns Number: 482206518

Premarket Exempt : Yes

Product Code : KJC

Prescription Use : Yes

Device Count : 1

RegenKit-THT-3/RegenCell® - 07640138981593 Catalog Number :

Device Description : Name of the kit: RegenKit®-THT-3 (20ml)/RegenCell®RegenKit-THT-3 containing 3 x Name of the kit: RegenKit®-THT-3 (20ml)/RegenCell®RegenKit-THT-3 containing 3 x R-THT20 tubes.

Device Class : 2

Duns Number: 482206518

Premarket Exempt : No

Product Code : FMI, FMF

Prescription Use : Yes

Device Count : 1

RegenKit-BCT-3 (20ml)/RegenPlasma - 07640138981630 Catalog Number :

Device Description : RegenKit-BCT-3 (20ml) containing 3 RegenBCT tubes 20 ml.

Device Class : 2

Duns Number: 482206518

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

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