HEALTHMARK INDUSTRIES CO., INC.

FDA Device Registration & Listing · Fraser, MI, US · Registration 1834190

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1834190
FEI Number
1000160387
Entity Name
HEALTHMARK INDUSTRIES CO., INC.
City/State/Country
Fraser, MI, US
Establishment Address
18600 Malyn Blvd., Fraser, MI 48026, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Healthmark (Owner Number: 9008981)
Owner / Operator Contact Address
18600 Malyn Blvd., --, Fraser, MI 48026, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SafeGuard Pro Ultra Clean Systems Sanizyme Disposable Bulb & Bladder Plastic Sterilizing Baskets Micro Protech Trays Instru-Trays Endoscope Soaking Basin

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2025-09-08
FLG Cleaner, Ultrasonic, Medical Instrument General Hospital Class 1 880.6150 2026-05-18
FFY Adaptor, Bulbs, Miscellaneous, For Endoscope Gastroenterology, Urology Class 1 876.1500 2025-09-09
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2009-06-24
PHT Basin For Endoscope Reprocessing Gastroenterology, Urology Class 1 876.1500 2024-03-15

Official Correspondent

James Chenard

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Healthmark
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2025 Young Dental Manufacturing I, LLC 1
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1834190. Last updated year: 2026. Please use registration number 1834190 when referencing this establishment in official correspondence.
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