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HARTMANN USA INC.

Last updated September 17, 2026

Information

Country: US
Address: 481 LAKESHORE PKWY., ROCK HILL, SC, 29730
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1218946
DUNS Number: —

Catalogue (178)

Page 2 of 4

Device	Model / Reference	Registries	Class	Status
Flexicol Sacral 6x7 5/Bx	48620000	FDA UDI	Class I	Active
Ac-Tape Plus	64310000 3X5 48/CS	FDA UDI	Class I	Active
Flex-Band Sm Strip 3/4 X 3 2400/Cs	46160000	FDA UDI	Class I	Active
Flex-Band Lg Strip 1 X 3 2400/Cs	46180000	FDA UDI	Class I	Active
PROXIMEL NON BORDER 6x6 5/BX	15713103	FDA UDI	Class I	Active
Novaplus Esmark V1862 6x12 20/Cs	18620073	FDA UDI	Class I	Active
Ac Tape	64400000 4X5 36/CS	FDA UDI	Class I	Active
Ac Tape 2x5 72/Cs	64200000	FDA UDI	Class I	Active
Shur-Band St 2x5 10/Cs	59920000	FDA UDI	Class I	Active
Flexicon St 6x4.1 48/Cs	19600000	FDA UDI	Class I	Active
Eze-Band Basic Sterile 6x10 24/cs	15800037	FDA UDI	Class I	Active
Pro's Choice 1.5x5 32/Cs	64740000	FDA UDI	Class I	Active
Esmark 6x9 St 20/Cs	18610000	FDA UDI	Class I	Active
Sorbalux Non-Adherent St 3x8 600/Cs	48910000	FDA UDI	Class I	Active
Flexicol Heel 3x5 10/Bx	48630000	FDA UDI	Class I	Active
ECONOLUX GZ NS 2X2 8PLY 5000/CS 14, 5tex	15700000	FDA UDI	Class I	Active
Esmark 4x12 St 20/Cs	18420000	FDA UDI	Class I	Active
ECONOLUX GZ 14, 5tex ST 4X4 8P (12x50xP2	416104	FDA UDI	Class I	Active
Novaplus Esmark V1831 3x9 20/Cs	18310073	FDA UDI	Class I	Active
Contex Lf St 2x5 10/Cs	50200000	FDA UDI	Class I	Active
ColActive Plus 4x4	10180000	FDA UDI	U	Active
PROXIMEL BASIC NON-BORDER 4x4 10/BX	15713107	FDA UDI	Class I	Active
Sterilux Gz Sponge St 4x4 12ply 1200/Cs	56910000	FDA UDI	Class I	Active
Eze-Band Lf St 2x5 36/Cs	59720000	FDA UDI	Class I	Active
Pros Choice Coh Wht 1.5x6 32/Pk	40195001	FDA UDI	Class I	Active
PROXIMEL NON BORDER 8x5 HEEL 5/BX	15713105	FDA UDI	Class I	Active
ECONOLUX GZ NS 4X4 16PLY 2000/CS 14, 5tex	416818	FDA UDI	Class I	Active
PROXIMEL NON BORDER 4x4 10/BX	15713100	FDA UDI	Class I	Active
Eze-Band Lf St 6x5.5 36/Cs	59760000	FDA UDI	Class I	Active
Contex Lf St 3x5 10/Cs	50300000	FDA UDI	Class I	Active
Proximel Silicone Dressing 6x6	14400000	FDA UDI	Class I	Active
Deluxe Lf St 6x5.5 20/Cs	27600000	FDA UDI	Class I	Active
Pro's Choice 1.5x7.5 32/Cs	64710000	FDA UDI	Class I	Active
Flexicol 6x6 5/Bx	48660000	FDA UDI	Class I	Active
Novaplus Esmark V1861 6x9 20/Cs	18610073	FDA UDI	Class I	Active
ATx Tape 2" x 15 Yd 24/Cs	15700001	FDA UDI	Class I	Unknown
Proximel Silicone Dressing 4x12	14500000	FDA UDI	Class I	Active
Sorbalux Non-Adherent St 3x4 2400/Cs	48900000	FDA UDI	Class I	Active
Shur-Band St 6x5 10/Cs	59960000	FDA UDI	Class I	Active
Contex Lf St 4x5 10/Cs	50400000	FDA UDI	Class I	Active
Sorbalgon T 2gram 30cm P5 C10	9995922	FDA UDI	Class I	Unknown
Sorbalgon 4x8 5/Bx	49230001	FDA UDI	Class I	Active
Proximel NB AG Silicone Dressing 8x8	15713119	FDA UDI	U	Active
Pros Choice Coh Wht 3x6 16/Pk	40195003	FDA UDI	Class I	Active
PROXIMEL BASIC NON-BORDER 2x2 10/BX	15713106	FDA UDI	Class I	Active
Ac-Tape Plus	65310000 TPK 3X5 16/CS	FDA UDI	Class I	Active
Proximel Ag Dressing Sm Sacral 5/Bx	15500000	FDA UDI	U	Active
Flexicol Thin 4x4 10/Bx	48640000	FDA UDI	Class I	Active
PROXIMEL AG SILICONE DRESSING 4x12 5/BX	15400000	FDA UDI	U	Active
Proximel Silicone Dressing Heel	14800000	FDA UDI	Class I	Active

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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
May 14, 2012	Z-1858-2012	—	terminated	Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
May 14, 2012	Z-1857-2012	—	terminated	Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
Feb 11, 2011	Z-1866-2011	—	terminated	Misbranded; the expiry date on the primary packing incorrectly indicates 2010-10, instead of 2015-10. Consignees were notified by letter on/about 02/11/2011. They were advised to examine their inventory and not to use any of the affected product and to return it to Paul Hartmann. A response form was included to be completed and returned to Paul Hartmann. They were further instructed to pass the no