Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003630504

FEI Number

3002468842

Entity Name

HARMAC MEDICAL PRODUCTS

City/State/Country

CASTLEREA Roscommon, IE

Establishment Address

I.D.A. BUSINESS PARK, CASTLEREA Roscommon --, IE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HARMAC MEDICAL PRODUCTS, INC. (Owner Number: 1317547)

Owner / Operator Contact Address

2201 BAILEY AVE., --, Buffalo, NY 14211, US

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
QEP	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	Microbiology	Class 2	866.3393	2022-12-07
QKL	Lipoaspirate Washing System For Aesthetic Body Contouring	General, Plastic Surgery	Class 2	878.5040	2023-03-14
PJQ	Agent, Occluding, Vascular, Permanent	Unknown	Class 3	N/A	2015-03-05
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2024-07-09
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2025-08-22
LNR	System, Photopheresis, Extracorporeal	Unknown	Class 3	N/A	2013-01-25
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2021-12-14
QKL	Lipoaspirate Washing System For Aesthetic Body Contouring	General, Plastic Surgery	Class 2	878.5040	2023-03-14

Official Correspondent

Nathan Monin

US Agent Details

Nathan Monin Business: Harmac Medical Products Email: nmonin@harmac.com Phone: (716) 8974500

Related Public Records

Same Entity

HARMAC MEDICAL PRODUCTS, 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
1317547	HARMAC MEDICAL PRODUCTS, INC.	BUFFALO, NY, US
3011163668	HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de R.L. de C.V.	Tijuana Baja California, MX

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0041-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

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3007420875	GeneOhm Sciences Canada, ULC.	Quebec, CA
3009613136	CEPHEID AB	SOLNA Stockholm, SE
3019837962	Abbott Molecular Distribution Center	Itasca, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003630504. Last updated year: 2026. Please use registration number 3003630504 when referencing this establishment in official correspondence.