Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016096098

FEI Number

3016096098

Entity Name

CENTERPIECE S. DE R.L DE C.V

City/State/Country

Playas de Rosarito Baja California, MX

Establishment Address

Avenidad de la Hospitalidad #505, Lucio Blanco, Playas de Rosarito Baja California 22710, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Centerpiece Holdings LLC (Owner Number: 10061801)

Owner / Operator Contact Address

420 Stevens Ave, Suite 230, Solana Beach, CA 92075, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Magnolia Medical ITW Medical/Coeur, Inc. Plenity AXP II AutoXpress Platform ITW Medical/Coeur, Inc. TAP Micro Select ITW Medical/Coeur, Inc. ITW Medical/Coeur, Inc.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2023-04-26
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2024-02-02
QFQ	Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss	Gastroenterology, Urology	Class 2	876.5982	2021-06-10
OAO	Cord Blood Processing System And Storage Container	Hematology	Class 2	864.9900	2023-11-07
OAO	Cord Blood Processing System And Storage Container	Hematology	Class 2	864.9900	2022-12-28
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2024-02-02
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2026-03-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-02-02
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2024-02-02
PQH	Iodinated Contrast Media Transfer Tubing Set	General Hospital	Class 2	880.5440	2024-02-02

Official Correspondent

JEFF HOVER

US Agent Details

Raza Mohammed Business: Global Director QA/RA Email: raza.mohammed@jcsaholdings.com Phone: (443) 5545486

Related Public Records

Same Entity

Centerpiece Holdings LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3019807891	CENTERPIECE S. DE R.L DE C.V (sterilization site)	Tijuana Baja California, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

Similar Registrations

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9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE
3005739529	Zhejiang Gongdong Medical Technology Co., Ltd	TAIZHOU Zhejiang, CN
1064584	DEMETECH CORP.	Miami Lakes, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016096098. Last updated year: 2026. Please use registration number 3016096098 when referencing this establishment in official correspondence.