Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005205657

FEI Number

3005205657

Entity Name

RMF Design and Manufacturing Inc.

City/State/Country

Mississauga Ontario, CA

Establishment Address

5675 Timberlea Blvd, Mississauga Ontario L4W 2S4, CA

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Makromed, Inc. (Owner Number: 10088725)

Owner / Operator Contact Address

88 STILES ROAD, Salem, NH 03079, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SONIK MONARK 100 NQ TMS for MDD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QTO	Digital Visual Acuity Test	Ophthalmic	Class 1	886.1150	2026-04-08
HPL	Device, Fixation, Ac-Powered, Ophthalmic	Ophthalmic	Class 1	886.1290	2026-04-08
LXM	Manipulator, Plunger-Like Joint	Unknown	Class U	N/A	2026-01-27
PJZ	Camera, Ophthalmic, General-Use	Ophthalmic	Class 2	886.1120	2026-04-08
HJR	Stereoscope, Battery-Powered	Ophthalmic	Class 1	886.1870	2026-04-08
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2026-03-13
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2024-01-31
HLG	Pupillometer, Ac-Powered	Ophthalmic	Class 1	886.1700	2026-04-08

Official Correspondent

Barry Ashar

US Agent Details

Barry Ashar Business: MAKROMED, INC. Email: bashar@makromed.com Phone: (603) 6749074

Related Public Records

Same Entity

Makromed, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3029464335	MAKROMED, INC.	Salem, NH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243700	Mag & More GmbH	Apollo TMS Therapy System	2025-09-04
K231926	Neuronetics, Inc.	NeuroStar Advanced Therapy System (All previously cleared models)	2024-03-22

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005205657. Last updated year: 2026. Please use registration number 3005205657 when referencing this establishment in official correspondence.