REGEN LAB SA

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

Platelet And Plasma Separator For Bone Graft Handling (ORG) (6) Syringe, Piston (FMF) (3) Needle, Hypodermic, Single Lumen (FMI) (2)

Premarket Exempt

No Yes

Clear

RegenKit®-BCT-2 Plus - 07640138980039 Catalog Number :

Device Class : 2

Duns Number: 482206518

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

RegenKit®-BCT-1 Plus - 07640138980138 Catalog Number :

Device Class : 2

Duns Number: 482206518

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

A-CP-Kit-1 - 07640138980190 Catalog Number :

Device Class : 2

Duns Number: 482206518

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

Regen Spray Applicator - 07640138980220 Catalog Number :

Device Class : 2

Duns Number: 482206518

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

RegenKit®-THT-1/RegenCell® - 07640138980244 Catalog Number :

Device Class : 2

Duns Number: 482206518

Premarket Exempt : No

Product Code : FMI, FMF

Prescription Use : Yes

Device Count : 1

RegenKit®-THT-4/RegenCell® - 07640138980251 Catalog Number :

Device Class : 2

Duns Number: 482206518

Premarket Exempt : No

Product Code : FMI, FMF

Prescription Use : Yes

Device Count : 1

RegenKit®-BCT-1 - 07640138980268 Catalog Number :

Device Class : 2

Duns Number: 482206518

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

RegenKit®-BCT-2 - 07640138980275 Catalog Number :

Device Class : 2

Duns Number: 482206518

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

RegenKit®-BCT-4 - 07640138980282 Catalog Number :

Device Class : 2

Duns Number: 482206518

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

Accessory Set - 07640138980329 Catalog Number :

Device Class :

Duns Number: 482206518

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

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