Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615395

FEI Number

3005246281

Entity Name

AIKEN MEDICAL SUPPLIES INC.

City/State/Country

MILTON Ontario, CA

Establishment Address

80 ELIZABETH ST, MILTON Ontario L9T6R7, CA

Establishment Type(s)

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

Owner / Operator

AIKEN MEDICAL SUPPLIES (Owner Number: 9034577)

Owner / Operator Contact Address

80 ELIZABETH ST., --, MILTON, CA-ON L9T 6R7, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

URIOAID FEMALE URINE COLLECTION AID

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	1998-07-28

Official Correspondent

MANUELA AIKEN

US Agent Details

RON PRYBELLA Business: Medegen Medical Products Email: ron.prybella@medegenmed.com Phone: (631) 9836730

Related Public Records

Same Entity

AIKEN MEDICAL SUPPLIES

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3027605742	Xiamen Zhiyuan Medical Technology Co., Ltd.	XIAMEN Fujian, CN
2320762	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US
3010420046	CITOTEST Labware Manufacturing CO., LTD.	Haimen Jiangsu, CN
3044466317	MEDINOVA GROUP CO.	Laguna Beach, CA, US
1055236	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615395. Last updated year: 2026. Please use registration number 9615395 when referencing this establishment in official correspondence.