Regen Lab SA

CH-MF-000032231 · Switzerland · Le Mont-sur-Lausanne

Regen Lab SA is registered in the European database on medical devices as a manufacturer, with 51 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb	32
Class I	11
Class IIa	8

Among these devices, 51 are declared sterile, 11 implantable, 48 active.

Authorised representative in the Union: RegenLab France.

Devices declared under this manufacturer

A-CP-Kit-1
A-CP-Kit-3 (20ml)
A-CP-Kit-T (20ml)
Cellular Matrix A-CP-HA Kit
Cellular Matrix A-CP-HA-1
Cellular Matrix BCT-HA Kit
RegenCT
RegenET
RegenFibrin Polymer 2
RegenKit Extracell BMC2
RegenKit-BCT-1
RegenKit-BCT-2

Showing 12 of 51 declared devices.

Catalogue references include A-CP-1, A-CP-HA-1, A-CP-HA-3, R-ET-3, R-FP2/T, RK-BCT-1.

European nomenclature codes declared: B0501,B0599, P900402, B06, B019001, B0199, V9099.

United States market access

FDA establishment register	Registered with FDA
Matched entry	REGEN LAB Sa (CH) · FDA 3008496303
Devices in EUDAMED	51
Country of registration	Switzerland

Device-level evidence

Devices with a numeric GTIN	51
Found in the U.S. device database	5
Share	9.8 %

Canadian market access

Health Canada licence listing	Licensed in Canada
Matched entry	REGEN LAB SA

What it holds in Canada

Licences on record	6
Currently active	0
Class 2 devices	6
First licensed	2010-11-23

Licence types: Device Group Family (5), Device Group (1).

Licensed under: REGENKIT-THT, TROUSSES REGEN ACR-C, REGEN SPRAY APPLICATOR, REGENKIT-BCT, REGENKIT EXTRACELL, ACCESSORY SET FOR BLOOD COLLECTION.

North American profile: Both markets. Regen Lab SA is registered in both the United States and Canada.

Notified body certificates

Certificate	Status	Expiry
`MDR 756199`	supplemented	2028-04-24
`MDR 756198`	supplemented	2028-04-24
`MDR 755931`	supplemented	2028-04-24

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