Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000359047

FEI Number

1000359047

Entity Name

Baxter R&D Europe SPRL

City/State/Country

Braine-l'Alleud Wallonia, BE

Establishment Address

Boulevard d'Angleterre 2-4, Braine-l'Alleud Wallonia 1420, BE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

BAXTER HEALTHCARE CORPORATION (Owner Number: 1417572)

Owner / Operator Contact Address

One Baxter Parkway, Deerfield, IL 60015, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P050011

All Registered Proprietary Names

Fibrinotherm Duploject Duo Set Due Set A Spray Set for Tisseel Coseal Surgical Sealant EasySpray ARS-530 Air Regulator System Adept

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JRG	Block, Heating	Clinical Chemistry	Class 1	862.2050	2015-01-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2017-08-18
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2015-01-22
NBE	Sealant, Polymerizing	Unknown	Class 3	N/A	2015-01-22
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2015-01-22
MCN	Barrier, Absorbable, Adhesion	Unknown	Class 3	N/A	2015-01-22

Official Correspondent

Maha Nolasco

US Agent Details

Maha Nolasco Business: Baxter Healthcare Corporation Email: maha_nolasco@baxter.com Phone: (224) 2706181

Related Public Records

Same Entity

BAXTER HEALTHCARE CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014226707	BARDY DIAGNOSTICS, INC.	Bellevue, WA, US
3019257308	VIDEOMED SRL	LIMENA Padova, IT
1314492	Baxter Healthcare Corporation	MEDINA, NY, US
3007143268	Baxter Medical Systems GmbH + Co. KG	SAALFELD Thuringia, DE
8010130	BAXTER SA	LESSINES Hainaut, BE

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

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 1000359047. Last updated year: 2026. Please use registration number 1000359047 when referencing this establishment in official correspondence.