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HEALTHMARK INDUSTRIES CO., INC.

United States·US-MF-000047536

Last updated September 17, 2026

Information

Country: United States
Address: 18600 Mayln Blvd, Fraser, United States
Website: www.hmark.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +15867747600
PRRC Contact: Jamie Chenard
EUDAMED SRN: US-MF-000047536
FDA FEI Number: 1000160387
DUNS Number: —

Catalogue (158)

Page 2 of 4

Device	Model / Reference	Registries	Class	Status
Decontam Exam Gloves	TDG-4-500	FDA UDI	Class I	Active
Ultra Long Decontam Exam Gloves	ULDG-4-50	FDA UDI	Class I	Active
Endoscope Brushes	CC-230-400	FDA UDI	Class I	Active
Endoscope Brushes	EBR-374	FDA UDI	Class I	Active
Protech ™ Trays	113-1314H	FDA UDI	Class I	Active
Protech ™ Trays	PSST-002	FDA UDI	Class I	Active
Decontam Exam Gloves	TDG-1-50	FDA UDI	Class I	Active
Protech ™ Trays	30732-H	FDA UDI	Class I	Active
Endoscope Brushes	CC2-230-600	FDA UDI	Class I	Active
Endoscope Brushes	CC2-100-200	FDA UDI	Class I	Active
Protech ™ Trays	41013 RD	FDA UDI	Class I	Active
Endoscope Brushes	CC-172-3770	FDA UDI	Class I	Active
Endoscope Brushes	CC2-025-600	FDA UDI	Class I	Active
Protech ™ Trays	PSST-005	FDA UDI	Class I	Active
Protech ™ Trays	PSST-003	FDA UDI	Class I	Active
Protech ™ Trays	41116H BL	FDA UDI	Class I	Active
Protech ™ Trays	30842	FDA UDI	Class I	Active
Ultra Long Decontam Exam Gloves	ULDG-1-50	FDA UDI	Class I	Active
Disposable Bulb & Bladder	D30200-210	FDA UDI	Class I	Active
Protech ™ Trays	41116 BL	FDA UDI	Class I	Active
Protech ™ Trays	75.0005.5	FDA UDI	Class I	Active
Protech ™ Trays	41116 RD	FDA UDI	Class I	Active
Protech ™ Trays	31042	FDA UDI	Class I	Active
Endoscope Brushes	CC-230-900	FDA UDI	Class I	Active
Protech ™ Trays	41116 MV	FDA UDI	Class I	Active
Protech ™ Trays	41116H MV	FDA UDI	Class I	Active
Protech ™ Trays	4106 PP	FDA UDI	Class I	Active
Sterile Bulb & Bladder	SBB-01-5	FDA UDI	Class I	Active
Protech ™ Trays	75.0194.4	FDA UDI	Class I	Active
Decontam Exam Gloves	TDG-4-50	FDA UDI	Class I	Active
Protech ™ Trays	PSST-007	FDA UDI	Class I	Active
Endoscope Brushes	CC2-200-200-3770	FDA UDI	Class I	Active
Protech ™ Trays	4106H PP	FDA UDI	Class I	Active
Protech ™ Trays	41317 BL	FDA UDI	Class I	Active
Endoscope Brushes	CC2-230-400	FDA UDI	Class I	Active
Protech ™ Trays	41013H RD	FDA UDI	Class I	Active
Protech ™ Trays	41013H MV	FDA UDI	Class I	Active
Protech ™ Trays	PSST-009	FDA UDI	Class I	Active
Endoscope Brushes	EBR-110-3770	FDA UDI	Class I	Active
Decontam Exam Gloves	TDG-2-500	FDA UDI	Class I	Active
Protech ™ Trays	31772-22	FDA UDI	Class I	Active
Endoscope Brushes	EBR-374-3770	FDA UDI	Class I	Active
Endoscope Brushes	CC-374-3770	FDA UDI	Class I	Active
Endoscope Brushes	EBR-601-3770	FDA UDI	Class I	Active
Endoscope Brushes	EBR-110	FDA UDI	Class I	Active
Endoscope Brushes	CC-200-200	FDA UDI	Class I	Active
Disposable Bulb & Bladder	D30200-210S	FDA UDI	Class I	Unknown
Angled Toothbrush	3184-10	FDA UDI	Class I	Active
Decontam Exam Gloves	TDG-3-500	FDA UDI	Class I	Active
Protech ™ Trays	PSST-008	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Lta Medical FR

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 12, 2026	Z-1943-2026	—	open, classified	Product does not have FDA clearance.
May 2, 2025	Z-1910-2025	—	open, classified	During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.
May 2, 2025	Z-1909-2025	—	open, classified	During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.