Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038295170

FEI Number

3038295170

Entity Name

Illumix Surgical Canada Inc.

City/State/Country

Toronto Ontario, CA

Establishment Address

365 Bay St. Suite 800, Toronto Ontario M5H 2V1, CA

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Illumix Surgical Canada Inc. (Owner Number: 10093282)

Owner / Operator Contact Address

365 Bay St. Suite 800, Toronto, CA-ON M5H 2V1, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Illumix Retractor Alpha

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2025-04-23

Official Correspondent

No official correspondent registered.

US Agent Details

Matt Kyle Business: Kuro Medical LLC Email: quality@kuromedical.com Phone: (612) 6362035

Related Public Records

Same Entity

Illumix Surgical Canada Inc.

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
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number	Establishment Name	Location
3011050528	FREEHOLD SURGICAL, INC.	New Hope, PA, US
3021006167	KIMS MED CO., LTD.	Gwangju, KR
3045009502	WISDOM MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD	Shanghai, CN
3032847175	BIOPHYX SURGICAL, INC.	Edgewater, MD, US
9681129	BEMA-GMBH & CO. KG	EMMINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038295170. Last updated year: 2026. Please use registration number 3038295170 when referencing this establishment in official correspondence.