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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 1 of 4

Device	Model / Reference	Registries	Class	Status
ColActive Plus AG 2x2 600/cs	10330000	FDA UDI	U	Active
Proximel Silicone Dressing 3x3	14100000	FDA UDI	Class I	Active
Eze-Band Lf St 4x5.5 36/Cs	59740000	FDA UDI	Class I	Active
Co-Lastic Lf Tan 2x5 36/Cs	45960000	FDA UDI	Class I	Active
Proximel NB AG Silicone Dressing 4x4	15713117	FDA UDI	U	Active
Ac Tape	64300000 3X5 48/CS	FDA UDI	Class I	Active
COLACTIVE PLUS 7x7 10/BX	10350000	FDA UDI	U	Active
Deluxe Lf St 2x5.5 20/Cs	27200000	FDA UDI	Class I	Active
STERILUX AMD ST BULKY GZ 4.5x4.1YD 6P	15713135	FDA UDI	U	Active
Sterilux Bulky Gz St 4.5x4.1 100/Cs	83500000	FDA UDI	Class I	Active
Proximel Silicone Dressing 5x5	14300000	FDA UDI	Class I	Active
Proximel Silicone Dressing 4x4	14200000	FDA UDI	Class I	Active
Novaplus #v5020 St 2x5 10/Cs	50200073	FDA UDI	Class I	Active
Deluxe Lf St 4x5.5 20/Cs	27400000	FDA UDI	Class I	Active
Pro's Choice 3x5 16/Cs	64760000	FDA UDI	Class I	Active
Ac-Tape Plus	65210000 TPK 2X5 24/CS	FDA UDI	Class I	Active
PROXIMEL NON BORDER 8x8 5/BX	15713104	FDA UDI	Class I	Active
Flexicon St 1x4.1 96/Cs	19100000	FDA UDI	Class I	Active
Flexicon St 2x4.1 96/Cs	19200000	FDA UDI	Class I	Active
Flexband Patch 2x3 1200/Cs	46130000	FDA UDI	Class I	Active
Ac Tape	64100000 AC TAPE 1X5 144/CS	FDA UDI	Class I	Active
Sorbalgon 4x4 10/Bx	49210000	FDA UDI	Class I	Unknown
Eze-Band Lf St 3x5 36/Cs	59730000	FDA UDI	Class I	Active
Sorbalgon Ag st 15x15cm P5	999610	FDA UDI	U	Active
Deluxe Lf St 6x11 20/Cs	28600000	FDA UDI	Class I	Active
PROXIMEL BASIC NON-BORDER 3.2x3.2 10/BX	15713110	FDA UDI	Class I	Active
Novaplus Esmark V1841 4x9 20/Cs	18410073	FDA UDI	Class I	Active
SORBALUX ABD PAD ST 3x5 400/CS	15700004	FDA UDI	Class I	Active
Sorbalgon 4x4 10/Bx	49210001	FDA UDI	Class I	Active
Novaplus #v5040 St 4x5 10/Cs	50400073	FDA UDI	Class I	Active
Novaplus Esmark V1832 3x12 20/Cs	18320073	FDA UDI	Class I	Active
ECONOLUX GZ NS 4X4 12PLY 2000/CS 14, 5tex	416817	FDA UDI	Class I	Active
Pro's Choice 2x5 24/Cs	64750000	FDA UDI	Class I	Active
Reb Lf St 6x5 10/Cs	34600000	FDA UDI	Class I	Active
Proximel Silicon Border Dressing 2x2 10P	14080000	FDA UDI	Class I	Active
Sorbalgon 2x2 10/Bx	49200000	FDA UDI	Class I	Unknown
Sorbalgon Ag st 5x5cm P10	999612	FDA UDI	U	Active
ECONOLUX GZ NS 4X4 8PLY 14, 5tex 4000/CS	416816	FDA UDI	Class I	Active
PROXIMEL BASIC 7x7 5/BX	15713115	FDA UDI	Class I	Active
Ac-Tape	65200000 TPK 2X5 24/CS	FDA UDI	Class I	Active
Eze-Band Lf St 6x11 24/Cs	59790000	FDA UDI	Class I	Active
Shur-Band St 4x5 10/Cs	59940000	FDA UDI	Class I	Active
Eze-Band Basic Sterile 4x5 36/cs	15800035	FDA UDI	Class I	Active
PROXIMEL BASIC 6x6 5/BX	15713114	FDA UDI	Class I	Active
ATx Tape 1 1/2" x 15 Yds 32/cs	15700000	FDA UDI	Class I	Unknown
Proximel Basic 4x4 10/Bx	15713112	FDA UDI	Class I	Active
Novaplus #v5030 St 3x5 10/Cs	50300073	FDA UDI	Class I	Active
Sorbalgon 1" x 12" Rope P5 C10	49220001	FDA UDI	Class I	Active
Proximel Silicone Dressing Small Sacral	14600000	FDA UDI	Class I	Active
Conco Conforming 4x4.1 St 96/Cs	81400000	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