Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006948745

FEI Number

3006948745

Entity Name

QLRAD

City/State/Country

Almere Flevoland, NL

Establishment Address

Damsluisweg 6, Almere Flevoland 1332 EC, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

QLRAD International Ltd. (Owner Number: 10025073)

Owner / Operator Contact Address

Damsluisweg 6, Almere, NL-FL 1332 EC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180478

PMA Number

N/A

All Registered Proprietary Names

Syringe Endorectal balloon

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-08-29
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-08-29
PCT	Prostate Immobilizer Rectal Balloon	Radiology	Class 2	892.5720	2018-11-19

Official Correspondent

Arjen Winkel

US Agent Details

EA Winkel Winkel Business: QLRAD Inc Email: awinkel@qlrad.com Phone: (305) 4378550

Related Public Records

Same Entity

QLRAD International Ltd.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010472281	Qlrad Inc	Miami, FL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
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-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
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

Similar Registrations

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3000214934	ALMAC PHARMA SERVICES LLC	Audubon, PA, US
3006850123	JAPAN IRRADIATION SERVICE CO., LTD	Naka-gun Ibaraki, JP
3029328631	PEGASUS IMPORTS	Houston, TX, US
3010621964	ATLAS MEDICAL PRODUCTS LLC	Hialeah, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006948745. Last updated year: 2026. Please use registration number 3006948745 when referencing this establishment in official correspondence.