Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012120143

FEI Number

3012120143

Entity Name

IMBIOTECHNOLOGIES LTD

City/State/Country

Edmonton Alberta, CA

Establishment Address

9650 20th Avenue, NW, Suite 215, Edmonton Alberta T6N 1G1, CA

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

IMBiotechnologies Ltd (Owner Number: 10051764)

Owner / Operator Contact Address

9650 20th Avenue, NW, Suite 215, Edmonton, CA-AB T6N 1G1, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K093813

PMA Number

N/A

All Registered Proprietary Names

Occlusin 500 Artificial Embolization Device Ekobi Embolization Microspheres

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2016-05-01

Official Correspondent

Michael Stewart

US Agent Details

Jamie Harris Business: ICON plc Email: jamie.harris@iconplc.com Phone: (661) 6459048

Related Public Records

Same Entity

IMBiotechnologies Ltd

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012120143. Last updated year: 2026. Please use registration number 3012120143 when referencing this establishment in official correspondence.