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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 4 of 4

Device	Model / Reference	Registries	Class	Status
Ac-Tape Plus 4x5 36/Cs	64410000	FDA UDI	Class I	Active
Proximel NB AG Silicone Dressing 6X6	15713118	FDA UDI	U	Active
Contex Lf St 6x5 10/Cs	50600000	FDA UDI	Class I	Active
Pros Choice Coh Wht 2x6 24/Pk	40195002	FDA UDI	Class I	Active
ECONOLUX GZ 14, 5tex ST 4X4 12P(24x25xP2)	416105	FDA UDI	Class I	Active
Sorbalux Abd Pad St 5x9 400/Cs	48700000	FDA UDI	Class I	Active
PROXIMEL BASIC NON-BORDER 8x8 5/BX	15713109	FDA UDI	Class I	Active
Sorbalgon 2x2 10/Bx	49200001	FDA UDI	Class I	Active
Conco Conforming 3x4.1 St 96/Cs	81300000	FDA UDI	Class I	Active
Novaplus #v5973 St 3x5 36/Cs	59730073	FDA UDI	Class I	Active
Proximel Silicone Dressing SM HEEL 5/BX	14090000	FDA UDI	Class I	Active
Esmark 3x12 St 20/Cs	18320000	FDA UDI	Class I	Active
Esmark 6x12 St 20/Cs	18620000	FDA UDI	Class I	Active
Conco Conforming 6x4.1 St 48/Cs	81600000	FDA UDI	Class I	Active
PROXIMEL NON BORDER 4x8 5/BX	15713102	FDA UDI	Class I	Active
Sorbalux Abd Pad St 7.5x8 240/Cs	48710000	FDA UDI	Class I	Active
Flex-Band Knuckle 1 1/2 X 3 2400/Cs	46140000	FDA UDI	Class I	Active
Sorbalgon Calcium Alginate 4x5	49240001	FDA UDI	Class I	Active
Flexicol 2x2 20/Bx	48600000	FDA UDI	Class I	Active
Sorbalgon 4x8 5/Bx	49230000 Sorbalgon 4x8 5/Bx	FDA UDI	Class I	Unknown
Flex-Band Lg Fingertip 2 X 2 1/2 1200/Cs	46210000	FDA UDI	Class I	Active
Sorbalux Purp Sponge St 4x4 4ply 1200/Cs	48880000	FDA UDI	Class I	Active
Novaplus #v5060 St 6x5 10/Cs	V5060	FDA UDI	Class I	Active
Sorbalux Purp Sponge 4x4 4ply 2000/Cs	48850000	FDA UDI	Class I	Active
Co-Lastic Lf Tan 2x5 36/Cs	45940000	FDA UDI	Class I	Active
Novaplus #v5976 St 6x5.5 36/Cs	59760073	FDA UDI	Class I	Active
Flex-Band Spot 7/8 Round 2400/Cs	46110000	FDA UDI	Class I	Active
Atrauman® Ag	K242758	FDA 510(k)	U	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