Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038139564

FEI Number

3038139564

Entity Name

MADEWELL MEDICAL TECHNOLOGY (MALAYSIA) SDN., BHD.

City/State/Country

Kuala Ketil Kedah, MY

Establishment Address

Lot 202, Kawasan Perindustrian Kuala Ketil,, Kuala Ketil Kedah 9300, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Madewell Medical Technology (Malaysia) Sdn., Bhd. (Owner Number: 10092929)

Owner / Operator Contact Address

Lot 202, Kawasan Perindustrian Kuala Ketil,, Kuala Ketil, MY-02 9300, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MADEWELL QiVi Acute MEC MEDLINE MADEWELL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2025-03-07
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2025-03-07
NZU	Collector, Urine, Powered, Non Indwelling Catheter	Gastroenterology, Urology	Class 1	876.5250	2025-03-07
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2025-03-07
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2025-03-07
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2025-03-07

Official Correspondent

Xu YaLin

US Agent Details

ZHENG XU Email: cathygeng2007@gmail.com Phone: (248) 5508758

Related Public Records

Same Entity

Madewell Medical Technology (Malaysia) Sdn., Bhd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2013	Cure Medical LLC	2	Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.

Similar Registrations

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3013055504	BONREE MEDICAL CO., LTD	Zhongshan Guangdong, CN
3012316249	COMPASS HEALTH BRANDS (CORPORATE OFFICE)	Middleburg Heights, OH, US
3009747810	NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD	Cixi Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038139564. Last updated year: 2026. Please use registration number 3038139564 when referencing this establishment in official correspondence.