Data / Medical devices / Switzerland / REGEN LAB Sa
REGEN LAB Sa: FDA-registered device maker in LE MONT-SUR-LAUSANNE Vaud, Switzerland, 1 510(k) clearance
REGEN LAB Sa is registered with the FDA (registration 3008496303) in LE MONT-SUR-LAUSANNE Vaud, Switzerland. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 9, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008496303
- Address
- En Budron B2, LE MONT-SUR-LAUSANNE Vaud, Switzerland, 1052
- Owner or operator
- RegenLab (10033110)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 13, 2010
- Registered through
- 2026
- Brand names listed
- A-CP-Kit Family Kits, CuteCell in vitro, Regen Spray Applicator, RegenET (ref: R-ET-3, R-ET-3 x 10), RegenKit - THT, RegenKit-BCT Family Kits:, RegenKit-BCT-1 Plus, RegenKit-BCT-2 Plus and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bottle, Roller, Tissue Culture | KJC | 1 | Manufacturer | accessdata.fda.gov |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 | Manufacturer | accessdata.fda.gov |
| Media And Components, Synthetic Cell And Tissue Culture | KIT | 1 | Manufacturer | accessdata.fda.gov |
| Peripheral Blood Processing Device For Wound Management | PMQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 9, 2012 | K122122 | REGEN SPRAY APPLICATOR, | FMF | Substantially Equivalent | Regen Lab SA | accessdata.fda.gov |
Compare with other makers
- All makers of Media And Components, Synthetic Cell And Tissue Culture
- All makers of Platelet And Plasma Separator For Bone Graft Handling
- All makers of Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- All makers of Peripheral Blood Processing Device For Wound Management
- All makers of Bottle, Roller, Tissue Culture
- All makers of Syringe, Piston
Updated November 9, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.