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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 3 of 4

Device	Model / Reference	Registries	Class	Status
Protech ™ Trays	4106 PK	FDA UDI	Class I	Active
Angled Toothbrush	3184-100	FDA UDI	Class I	Active
Decontam Exam Gloves	TDG-3-50	FDA UDI	Class I	Active
Endoscope Brushes	EBR-250	FDA UDI	Class I	Active
Protech ™ Trays	41317 RD	FDA UDI	Class I	Active
Ultra Long Decontam Exam Gloves	ULDG-1-500	FDA UDI	Class I	Active
Protech ™ Trays	31042-H	FDA UDI	Class I	Active
Protech ™ Trays	41013 BL	FDA UDI	Class I	Active
Protech ™ Trays	31055-H	FDA UDI	Class I	Active
Protech ™ Trays	NNB001	FDA UDI	Class I	Active
Protech ™ Trays	4116H BL	FDA UDI	Class I	Active
Endoscope Brushes	CC2-165-200	FDA UDI	Class I	Active
Protech ™ Trays	31772	FDA UDI	Class I	Active
Protech ™ Trays	31462	FDA UDI	Class I	Active
Protech ™ Trays	30842-H	FDA UDI	Class I	Active
Protech ™ Trays	4116 BL	FDA UDI	Class I	Active
Ultra Long Decontam Exam Gloves	ULDG-3-50	FDA UDI	Class I	Active
Protech ™ Trays	41317H MV	FDA UDI	Class I	Active
Face shield	SHL-003	FDA UDI	Class I	Active
Face shield	SHL-001	FDA UDI	Class I	Active
Protech ™ Trays	75.0005.4	FDA UDI	Class I	Active
Protech ™ Trays	PSST-001	FDA UDI	Class I	Active
Protech ™ Trays	PSST-010	FDA UDI	Class I	Active
Endoscope Brushes	EBR-172-3770	FDA UDI	Class I	Active
Protech ™ Trays	41013 GY	FDA UDI	Class I	Active
Protech ™ Trays	4106	FDA UDI	Class I	Active
Protech ™ Trays	4106H GN	FDA UDI	Class I	Active
Endoscope Brushes	CC-100-100	FDA UDI	Class I	Active
Protech ™ Trays	41520 BL	FDA UDI	Class I	Active
Protech ™ Trays	DT2-2136	FDA UDI	Class I	Active
Face shield	SHL-002	FDA UDI	Class I	Active
Ultra Long Decontam Exam Gloves	ULDG-3-500	FDA UDI	Class I	Active
Protech ™ Trays	PSST-011	FDA UDI	Class I	Active
Decontam Exam Gloves	TDG-2-50	FDA UDI	Class I	Active
Protech ™ Trays	31042-22	FDA UDI	Class I	Active
Protech ™ Trays	31772-H UNP	FDA UDI	Class I	Active
Instrument channel Brushes	GH-ICB-11061-50	EUDAMED	Class I	Active
Instrument channel Brushes	GH-ICB-16041-6	EUDAMED	Class I	Active
Vented Instrument Guards	GH-09-2-015	EUDAMED	Class I	Active
Instrument channel Brushes	GH-ICB-14041-1	EUDAMED	Class I	Active
Instrument channel Brushes	GH-ICB-06361-50	EUDAMED	Class I	Active
Instrument channel Brushes	GH-ICB-13061-3	EUDAMED	Class I	Active
Vented Instrument Guards	GH-09-2-019	EUDAMED	Class I	Active
Instrument channel Brushes	GH-ICB-04230-12	EUDAMED	Class I	Active
Cleaning Brushes	GH-221SN-3	EUDAMED	Class I	Active
Instrument channel Brushes	GH-ICB-16041-50	EUDAMED	Class I	Active
Instrument channel Brushes	GH-ICB-02046-1	EUDAMED	Class I	Active
Instrument channel Brushes	GH-ICB-02346-6	EUDAMED	Class I	Active
Cleaning Brushes	GH-3090	EUDAMED	Class I	Active
Cleaning Brushes	GH-3182-100	EUDAMED	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.