FDA Registration
Active
🇺🇸 United States
HEALTHMARK INDUSTRIES CO., INC.
Reg #: 1834190
·
FEI: 1000160387
·
Expires 2026
Products
6
Proprietary Names
9
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- HEALTHMARK INDUSTRIES CO., INC.
- Registration Number
- 1834190
- FEI Number
- 1000160387
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 18600 Malyn Blvd.
- City
- Fraser
- State
- MI
- ZIP
- 48026
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171533
Owner / Operator
- Firm Name
- Healthmark
- Operator Number
- 9008981
- Address
- 18600 Malyn Blvd., --
- City
- Fraser
- State
- MI
- Postal Code
- 48026
- Country
- US
- Correspondent
- James Chenard
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2025-09-08 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2026-05-18 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2025-09-09 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2009-06-24 |
| Basin For Endoscope Reprocessing | PHT | Class 1 | Gastroenterology, Urology | No | 2024-03-15 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2013-12-11 |
Proprietary Names
SafeGuard Pro
Ultra Clean Systems Sanizyme
Disposable Bulb & Bladder
Plastic Sterilizing Baskets
Micro Protech Trays
Instru-Trays
Endoscope Soaking Basin
EndoScope Brushes
SafeGuard Dry
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility