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The Hygenic Company, LLC

United States·US-MF-000003317

Last updated September 17, 2026

Information

Country: United States
Address: 1245, Home Avenue, Akron, United States
Website: performancehealth.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 331 688 9688
PRRC Contact: Melanie Leibowitz
EUDAMED SRN: US-MF-000003317
FDA FEI Number: 1519375
DUNS Number: —

Catalogue (307)

Page 6 of 7

Device	Model / Reference	Registries	Class	Status
TheraBand, 8’3” (2.5m), Red	20234	EUDAMED	Class I	Active
EU Theraband CLX Individual 11 Loops Pre-Cut Red	13220	EUDAMED	Class I	Active
Theraband, Resistance Bands Heavy Retail Pack	20413	EUDAMED	Class I	Active
Theraband® Professional Resistance Band 50 Yard Dispenser Silver	20170	EUDAMED	Class I	Active
Theraband, 50 Yard, Latex Free Black CE Mark	11850	EUDAMED	Class I	Active
Theraband 25 Yard Non-Latex Green CE Mark	50344	EUDAMED	Class I	Active
Theraband, Medium to Large Waist Belt	22001	EUDAMED	Class I	Active
TheraBand, 1.5m, DE Black – Special Heavy	13922	EUDAMED	Class I	Active
EU Theraband CLX Individual 11 Loops Pre-Cut Gold	13225	EUDAMED	Class I	Active
THERABAND Wellness Station Exercise Handles with "D" ring connector, set of 2	22121	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 1, Latex, 46M - Yellow	091145440	EUDAMED	Class I	Active
Theraband, 6 Yard, Tan Professional Resistance Band	20010	EUDAMED	Class I	Active
TheraBand Blue Non-Latex Tubing 100 ft	15495	EUDAMED	Class I	Active
HYGENIC FR Dental Dam Non-Latex, 6X6, Green, 1/pk Sample	15614	EUDAMED	Class I	Active
Theraband, 8’3” (2.5m), Leprello Pack - Yellow	20226L	EUDAMED	Class I	Active
Theraband Int’l High Resistance Band - Medium	15154	EUDAMED	Class I	Active
TheraBand, 8’3” (2.5m), Black	20264	EUDAMED	Class I	Active
Theraband, Resistance Tubes, Heavy Retail Pack	21313	EUDAMED	Class I	Active
TheraBand 12” Resistance Band Loop, Black	15447	EUDAMED	Class I	Active
Theraband, Resistance Tubing With Connectors, Green 12" Set Of 2	21640	EUDAMED	Class I	Active
TheraBand Silver Non-Latex Tubing 100 ft	15497	EUDAMED	Class I	Active
HYGENIC FR Dental Dam Non-Latex 6x6 Blue 30/pk	15561	EUDAMED	Class I	Active
Theraband, 5’, Black 15 Pack Dispenser - International	11882	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 3, Latex, 5.5M - Green	091145416	EUDAMED	Class I	Active
International Theraband CLX Bulk 22m (25 Yd) Roll - Silver	12783	EUDAMED	Class I	Active
TheraBand 8” Resistance Band Loop, Blue	20840	EUDAMED	Class I	Active
Theraband, Head Strap	22003	EUDAMED	Class I	Active
TheraBand 18” Resistance Band Loop, Yellow	20812	EUDAMED	Class I	Active
TheraBand 12” Resistance Band Loop, Yellow	20811	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 4, Latex, 46M - Blue	091145473	EUDAMED	Class I	Active
TheraBand 18” Resistance Band Loop, Black	15448	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 2, Latex, 5.5M - Red	091145408	EUDAMED	Class I	Active
Theraband® Professional Resistance Band 50 Yard Dispenser Black	20160	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 1, Non-Latex, 5M - Yellow	091338847	EUDAMED	Class I	Active
Theraband, Complete Set of 4, High Resistance Band	14950	EUDAMED	Class I	Active
HYGENIC HR Dental Dam Non-Latex 6x6 Teal 15/pk	15550	EUDAMED	Class I	Active
HYGENIC FR Dental Dam Non-Latex, 6X6, Blue, 1/pk Sample	15613	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 4, Non-Latex, 5M - Green	091338912	EUDAMED	Class I	Active
Theraband, 5’ Dispenser Pack, Green	20540	EUDAMED	Class I	Active
TheraBand, 5’, Blue	20253	EUDAMED	Class I	Active
International Theraband CLX Bulk 22m (25 Yd) Roll - Red	12779	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 2, Non-Latex, 1.5M - Red	091181858	EUDAMED	Class I	Active
Theraband 25 Yard Non-Latex Red CE Mark	50334	EUDAMED	Class I	Active
TheraBand 18” Resistance Band Loop, Silver)	15451	EUDAMED	Class I	Active
Theraband, Wall Station	21910	EUDAMED	Class I	Active
TheraBand 8” Resistance Band Loop, Yellow	20810	EUDAMED	Class I	Active
Theraband, 50 Yard, Latex Free Red CE Mark	11847	EUDAMED	Class I	Active
Theraband, 18”, Multi-color 4 Piece Band Loop Pack (Y, R, GR, BLU) - Latex	14730	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 3, Latex, 46M - Green	091145465	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 5, Latex, 25M - Black	091259753	EUDAMED	Class I	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

The Hygenic Corporation Batu Gajah Perak · MY FEI 3003123739