Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611712

FEI Number

3002807574

Entity Name

MEDIQUIP SDN. BHD.

City/State/Country

Kangar Perlis, MY

Establishment Address

Padang Lati Mukim Paya Batu 5 Jalan Santan, Kangar Perlis 02450, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Cardinal Health 200, LLC (Owner Number: 9028292)

Owner / Operator Contact Address

3651 Birchwood Drive, --, Waukegan, IL 60085, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K802875

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2007-12-17
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2013-02-01
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2018-07-27
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2018-07-27
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2013-01-23
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2018-07-27

Official Correspondent

No official correspondent registered.

US Agent Details

Stacey Henning Email: stacey.henning@cardinalhealth.com Phone: (312) 2702081

Related Public Records

Same Entity

Cardinal Health 200, 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
3004839227	Cardinal Health Malta 212 Ltd	Marsa, MT
3015541720	Cardinal Health Germany Manufacturing GmbH	Halberstadt Saxony-Anhalt, DE
1033903	Cardinal Health	Greenwood, SC, US
9611018	Cardinal Health Ireland Manufacturing Limited	TULLAMORE Offaly, IE
8040459	Kendall-Gammatron Limited	SAMPRAN Nakhon Pathom, TH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033719	C.R. Bard, Inc.	BARD TIGERTAIL URETERAL CATHETER	2004-02-04
K820239	American Endoscopy, Inc.	RETRIEVAL FORCEPS	1982-03-26
K041243	Tyco Healthcare	DOVER RED RUBBER ROBINSON CATHETER	2004-07-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2013	C.R. Bard, Inc., Urological Division	2	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.

Similar Registrations

Registration Number	Establishment Name	Location
9613662	MEDISCAN GMBH & CO. KG	KREMSMUNSTER Oberosterreich, AT
3008502431	HR PHARMACEUTICALS, INC d/b/a HR HealthCare	York, PA, US
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US
3006606901	COLOPLAST HUNGARY KFT	NYIRBATOR Szabolcs-Szatmar-Bereg, HU
3008806809	ConvaTec Limited, GDC Building	Deeside Flintshire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611712. Last updated year: 2026. Please use registration number 9611712 when referencing this establishment in official correspondence.