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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 (159)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
Protech ™ Trays	41317H BL	FDA UDI	Class I	Active
Protech ™ Trays	31772-22 UNP	FDA UDI	Class I	Active
Endoscope Brushes	EBR-172	FDA UDI	Class I	Active
Endoscope Brushes	CC2-230-600-LV11	FDA UDI	Class I	Active
Endoscope Brushes	EBR-601	FDA UDI	Class I	Active
Protech ™ Trays	4106 GN	FDA UDI	Class I	Active
Protech ™ Trays	31042-SC	FDA UDI	Class I	Unknown
Endoscope Brushes	CC-603	FDA UDI	Class I	Active
Protech ™ Trays	2006-4H	FDA UDI	Class I	Active
Protech ™ Trays	41116H GY	FDA UDI	Class I	Active
Protech ™ Trays	41013H GY	FDA UDI	Class I	Active
Protech ™ Trays	75.0005.6	FDA UDI	Class I	Active
Protech ™ Trays	75.0194.2	FDA UDI	Class I	Active
Protech ™ Trays	4106H	FDA UDI	Class I	Active
Protech ™ Trays	41317 GY	FDA UDI	Class I	Active
Protech ™ Trays	31462-H	FDA UDI	Class I	Active
Protech ™ Trays	PSST-013	FDA UDI	Class I	Active
Face shield	SHL-001-10	FDA UDI	Class I	Active
Protech ™ Trays	NNB002	FDA UDI	Class I	Active
Protech ™ Trays	DT2-1218	FDA UDI	Class I	Active
Endoscope Brushes	CC-230-900-3770	FDA UDI	Class I	Active
Protech ™ Trays	4106H PK	FDA UDI	Class I	Active
Endoscope Brushes	CC-230-600	FDA UDI	Class I	Active
Protech ™ Trays	30732	FDA UDI	Class I	Active
Endoscope Brushes	CC-230-400-3770	FDA UDI	Class I	Active
Endoscope Brushes	CC-603-3770	FDA UDI	Class I	Active
Endoscope Brushes	EBR-250-3770	FDA UDI	Class I	Active
Endoscope Brushes	CC-025-600	FDA UDI	Class I	Active
Decontam Exam Gloves	TDG-1-500	FDA UDI	Class I	Active
Endoscope Brushes	CC-230-600-3770	FDA UDI	Class I	Active
Endoscope Brushes	CC2-200-200-LV11	FDA UDI	Class I	Active
Protech ™ Trays	41116H RD	FDA UDI	Class I	Active
Protech ™ Trays	PSST-004	FDA UDI	Class I	Active
Protech ™ Trays	NNB003	FDA UDI	Class I	Active
Protech ™ Trays	31772-H	FDA UDI	Class I	Active
Ultra Long Decontam Exam Gloves	ULDG-4-500	FDA UDI	Class I	Active
Ultra Long Decontam Exam Gloves	ULDG-2-500	FDA UDI	Class I	Active
Protech ™ Trays	PSST-006	FDA UDI	Class I	Active
Ultra Long Decontam Exam Gloves	ULDG-2-50	FDA UDI	Class I	Active
Protech ™ Trays	41520H BL	FDA UDI	Class I	Active
Endoscope Brushes	CC-165-100	FDA UDI	Class I	Active
Endoscope Brushes	CC-200-200-3770	FDA UDI	Class I	Active
Protech ™ Trays	31462-22	FDA UDI	Class I	Active
Protech ™ Trays	31055	FDA UDI	Class I	Active
Endoscope Brushes	CC2-200-200	FDA UDI	Class I	Active
Protech ™ Trays	41317H GY	FDA UDI	Class I	Active
Protech ™ Trays	31772-22 TAN	FDA UDI	Class I	Active
Protech ™ Trays	41317H RD	FDA UDI	Class I	Active
Protech ™ Trays	41013H BL	FDA UDI	Class I	Active
Protech ™ Trays	PSST-012	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.