Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004070478

FEI Number

3004070478

Entity Name

URO TECHNOLOGY SDN. BHD.

City/State/Country

PONTIAN Johor, MY

Establishment Address

LOT 2491 BATU 39 1/2, PONTIAN BESAR, PONTIAN Johor 82000, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

URO TECHNOLOGY SDN. BHD. (Owner Number: 10058118)

Owner / Operator Contact Address

Lot 2491, Batu 39 1/2, Pontian Besar, Pontian, MY-01 82000, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

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
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2018-07-17
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2024-12-02

Official Correspondent

Khairunnisa Warsito

US Agent Details

DAVIN WEDEL Email: davin@globalprotection.com Phone: (617) 9462800

Related Public Records

Same Entity

URO TECHNOLOGY 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-0012-2023	Hobbs Medical, Inc.	2	Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 3412

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1000393132	COOK INCORPORATED	ELLETTSVILLE, IN, US
1825146	Cook Incorporated	Spencer, IN, US
3010155661	Synergy Health Sterilisation UK Ltd	Thorne Doncaster, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004070478. Last updated year: 2026. Please use registration number 3004070478 when referencing this establishment in official correspondence.