Regenlab S A

FDA Filings

This page includes the latest FDA filings for Regenlab S A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3008496303
FEI Number3008496303
NameREGEN LAB Sa
Owner & OperatorRegenLab SA
Contact AddressEn Budron B-2
Le Mont-sur-Lausanne CH-VD Vaud 1052 CH
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressEN BUDRON B-2
LE MONT-SUR-LAUSANNE Vaud, 1052 CH
Establishment TypeManufacture Medical Device



Registration Number3010512490
FEI Number3010512490
NameRegenlab USA LLC
Owner & OperatorRegenLab SA
Contact AddressEn Budron B-2
Le Mont-sur-Lausanne CH-VD Vaud 1052 CH
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address575 Madison Ave Ste 1006
New York, NY 10022 US



FDA Filings

Device
Company
DeviceDate
RegenLab SA
Peripheral Blood Processing Device For Wound Management2022-07-08
REGEN LAB Sa [RegenLab SA]
RegenET (ref: R-ET-3)2015-06-30
REGEN LAB Sa [RegenLab SA]
RegenKit-BCT-2 Plus2014-05-16
REGEN LAB Sa [RegenLab SA]
RegenKit-BCT-1 Plus2014-05-16
REGEN LAB Sa [RegenLab SA]
A-CP-Kit Family Kits2014-04-11
RegenLab SA
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 2014-02-05
RegenLab SA
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 2013-08-08
REGEN LAB Sa [RegenLab SA]
Regen Spray Applicator2013-02-08
REGEN LAB Sa [RegenLab SA]
RegenKit-BCT Family Kits:2012-06-27
RegenLab SA
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 2012-05-08
REGEN LAB Sa [RegenLab SA]
Stryker Universal Centrifuge2011-08-04
REGEN LAB Sa [RegenLab SA]
RegenKit - THT2010-07-13
RegenLab SA
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 2010-05-18

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