REGEN SPRAY APPLICATOR,
REGEN LAB SA
REGEN LAB Sa
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008496303 | 3008496303 | REGEN LAB Sa | 1 | N | 2026-01-01 | EN BUDRON B2 LE MONT-SUR-LAUSANNE Vaud CH 1052 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 119097 | 1163020400 | K122122 | REGEN SPRAY APPLICATOR, | FMF | 2012-11-09 |
| 119097 | 1178928953 | BK120066 | |||
| 119097 | 1029727989 | BK120057 | |||
| 119097 | 1053063911 | BK110061 | |||
| 119097 | 1983540782 | BK090048 | |||
| 119097 | 1012423311 | ||||
| 119097 | 1765109681 | ||||
| 119097 | 1849072086 | ||||
| 119097 | 1955429822 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FMF | 1 | 2012-11-09 |
PMN#
GUDID#
RegenKit®-THT-4 - 8495-9-004
2016-09-15
A-CP-Kit-3 (8ml) - A-CP-Kit-3 (8ml) containing 3 x A-CP 8 ml tubes.
2023-01-20
RegenPlasma/RegenKit-Woud Gel-2 - The RegenKit®-Wound Gel-2 contains 2 RegenWound PRP Tubes and 1 RegenWound ATS Tube. INTENDED USE / INDICATIONS FOR USERegenKit®-Wound Gel-2 is designed to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel (RegenWound Gel) from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the RegenWound Gel is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers and diabetic ulcers, and mechanically or surgically debrided wounds.
2023-01-19
RegenET - Kit containing 20 x R-ET-3 in a carton box
2022-06-28
RegenKit-BCT-3 (20ml)/RegenPlasma - RegenKit-BCT-3 (20ml) containing 3 RegenBCT tubes 20 ml.
2022-04-02
RegenKit-THT-3/RegenCell® - Name of the kit: RegenKit®-THT-3 (20ml)/RegenCell®RegenKit-THT-3 containing 3 x R-THT20 tubes.
2021-10-26
RegenET - R-ET-3 x 10
2020-11-19
Accessory Set - BCA-SET3-20
2020-11-05
Accessory Set - BCA-SET3
2020-10-13
Accessory Set - BCA-SET3-U
2020-10-05
RegenET - R-ET-3
2020-02-24
RegenKit®-THT-1/RegenCell® - RK-THT-1
2019-06-17
RegenKit®-THT-4/RegenCell® - RK-THT-4
2019-06-17
RegenKit®-THT-2/RegenCell® - RK-THT-2
2019-06-17
RegenKit®-BCT-2 Plus - RK-BCT-2A
2016-09-15
RegenKit®-BCT-1 Plus - RK-BCT-1A
2016-09-15
A-CP-Kit-1 - A-CP-1
2016-09-15
Regen Spray Applicator - R-A/NAC1
2016-09-15
RegenKit®-BCT-1 - RK-BCT-1
2016-09-15
RegenKit®-BCT-2 - RK-BCT-2
2016-09-15
RegenKit®-BCT-4 - RK-BCT-4
2016-09-15
RegenKit®-THT-3 - RK-THT-3
2016-09-15
RegenKit®-BCT-3 - RK-BCT-3
2016-09-15
A-CP-Kit-3 - A-CP-3
2016-09-15
A-CP-Kit-2 - A-CP-2
2016-09-15
A-CP-Kit-4 - A-CP-4
2016-09-15
RegenKit®-THT - 8495-9-001
2016-09-15
RegenKit®-THT-2 - 8495-9-002
2016-09-15