Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008496303

FEI Number

3008496303

Entity Name

REGEN LAB Sa

City/State/Country

LE MONT-SUR-LAUSANNE Vaud, CH

Establishment Address

EN BUDRON B2, LE MONT-SUR-LAUSANNE Vaud 1052, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RegenLab (Owner Number: 10033110)

Owner / Operator Contact Address

95 Greene St, Jersey City, NJ 07302, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK120066

PMA Number

N/A

All Registered Proprietary Names

RegenKit - THT RegenKit®-Wound Gel-2 A-CP-Kit Family Kits CuteCell in vitro RegenKit-BCT Family Kits: Regen Spray Applicator Stryker Universal Centrifuge RegenET (ref: R-ET-3, R-ET-3 x 10) RegenKit-BCT-1 Plus RegenKit-BCT-2 Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2010-07-13
PMQ	Peripheral Blood Processing Device For Wound Management	Hematology	Class 2	864.9245	2023-02-24
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2014-04-11
KIT	Media And Components, Synthetic Cell And Tissue Culture	Hematology	Class 1	864.2220	2021-06-23
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2012-06-27
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-02-08
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2011-08-04
KJC	Bottle, Roller, Tissue Culture	Hematology	Class 1	864.2240	2015-06-30
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2014-05-16

Official Correspondent

No official correspondent registered.

US Agent Details

Giuseppe Calloni Business: RegenLab USA Email: gcalloni@regenlabusa.com Phone: (332) 9996604

Related Public Records

Same Entity

RegenLab

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010512490	Regenlab USA LLC	Jersey City, NJ, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K832690	Sigma Chemical Co.	MINIMUM ESSENTIAL MED. EAGLE M0268	1983-09-12
K861867	Hazleton Research Products, Inc.	MEM ALPHA EAGLE MEDIUM	1986-05-29
K821916	Dutchland Laboratories, Inc.	IMPROVED MEM-RICHTER'S POWDER MODIF.	1982-07-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008496303. Last updated year: 2026. Please use registration number 3008496303 when referencing this establishment in official correspondence.