Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010512490

FEI Number

3010512490

Entity Name

Regenlab USA LLC

City/State/Country

Jersey City, NJ, US

Establishment Address

95 Greene St, Jersey City, NJ 07302, US

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

BK210661

PMA Number

N/A

All Registered Proprietary Names

A-CP-Kit Family Kits RegenKit-BCT-1 Plus RegenKit-BCT-2 Plus RegenKit - THT RegenET (ref: R-ET-3, R-ET-3 x 10) RegenBMC RegenKit-BCT Family Kits: RegenKit®-Wound Gel-2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-08-23
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2014-04-11
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2022-11-29
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2022-11-29
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2014-05-16
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2010-07-13
KJC	Bottle, Roller, Tissue Culture	Hematology	Class 1	864.2240	2015-06-30
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2022-11-29
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2026-06-16
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2012-06-27
PMQ	Peripheral Blood Processing Device For Wound Management	Hematology	Class 2	864.9245	2023-02-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3008496303	REGEN LAB Sa	LE MONT-SUR-LAUSANNE Vaud, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010512490. Last updated year: 2026. Please use registration number 3010512490 when referencing this establishment in official correspondence.