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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 4 of 7

Device	Model / Reference	Registries	Class	Status
Theraband, 6 Yard, Green Professional Resistance Band	20040	EUDAMED	Class I	Active
TheraBand 8” Resistance Band Loop, Red	20820	EUDAMED	Class I	Active
Theraband Exercis Handles	22120	EUDAMED	Class I	Active
TheraBand 18” Resistance Band Loop, Green	20832	EUDAMED	Class I	Active
TheraBand 12” Multi-Color 3Pk Loop Blk/Sil/Gold Latex	15455	EUDAMED	Class I	Active
TheraBand Black Non-Latex Tubing 100 ft	15496	EUDAMED	Class I	Active
HYGENIC Dental Dam 6x6 GREEN THIN 36/pk	15498	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 5, Non-Latex, 50M - Black	091339035	EUDAMED	Class I	Active
TheraBand, 2.5m, DE Black – Special Heavy	13927	EUDAMED	Class I	Active
TheraBand Latex Free Beginner Pack – International	11883	EUDAMED	Class I	Active
Theraband Padded Bar with D-Ring Connectors	22150	EUDAMED	Class I	Active
THERABAND Elastic Resistance Assist Device	22010	EUDAMED	Class I	Active
Theraband, 8’3” (2.5m), Leprello Pack - Green	20243L	EUDAMED	Class I	Active
HYGENIC Dental Dam, 6X6, Blue, Med, 1/pk Sample	15610	EUDAMED	Class I	Active
HYGENIC Dental Dam, 6X6, Green, Med, 1/pk Sample	15607	EUDAMED	Class I	Active
TheraBand 8” Resistance Band Loop, Gold	15452	EUDAMED	Class I	Active
Theraband, 5’, Yellow 15 Pack Dispenser - International	11878	EUDAMED	Class I	Active
Theraband, 5’, Green 15 Pack Dispenser - International	11880	EUDAMED	Class I	Active
HYGENIC HR Dental Dam Non-Latex 5x5 Teal 15/pk	15552	EUDAMED	Class I	Active
Theraband, 6 Yard, Black Professional Resistance Band	20060	EUDAMED	Class I	Active
EU Theraband CLX Individual 11 Loops Pre-Cut Black	13223	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 1, Latex, 5.5M - Yellow	091145390	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 5, Non-Latex, 1.5M - Black	091192004	EUDAMED	Class I	Active
Rolyan ExercisRolyan Exercise Band, Level 1, Non-Latex, 50M - Yellowe Band, Level 5, Non-Latex, 5M - Black	091338946	EUDAMED	Class I	Active
Theraband, 5’, Blue 15 Pack Dispenser - International	11881	EUDAMED	Class I	Active
Theraband, 8’3” (2.5m), Leprello Pack - Blue	20255L	EUDAMED	Class I	Active
Hygenic FR Framed Dental Dam Non-Latex, Purple, 1/PK Sample	15615	EUDAMED	Class I	Active
TheraBand Green Non-Latex Tubing 100 ft	15494	EUDAMED	Class I	Active
TheraBand 18” Resistance Band Loop, Red	20822	EUDAMED	Class I	Active
Theraband, Resistance Tubing With Connectors, Red 24" Set Of 2	21632	EUDAMED	Class I	Active
Theraband® Professional Resistance Band 50 Yard Dispenser Gold	20180	EUDAMED	Class I	Active
Theraband, Resistance Tubing Loop with Padded Cuffs, Green	21432	EUDAMED	Class I	Active
Theraband® Professional Resistance Band 50 Yard Dispenser Blue	20150	EUDAMED	Class I	Active
EU Theraband CLX Individual 11 Loops Pre-Cut Green	13221	EUDAMED	Class I	Active
TheraBand, 5’ (12.8cm wide x 150cm long), Yellow	20224	EUDAMED	Class I	Active
"thera-Band Exercise Station (exercise Station, Wall Station) - Accessory"	14013	EUDAMED	Class I	Active
Theraband, Resistance Tubing with Connectors, Blue 24” Set of 2	21652	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 2, Non-Latex, 50M - Red	091338953	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 4, Latex, 1.5M - Blue	091191964	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 1, Non-Latex, 1.5M - Yellow	091524909	EUDAMED	Class I	Active
Theraband, CLX 9 Loop Med Intensity 2-Pack Blue-Black	15444	EUDAMED	Class I	Active
TheraBand 12” Resistance Band Loop, Green	20831	EUDAMED	Class I	Active
TheraBand, 1.5m, DE Blue – Extra Heavy	13921	EUDAMED	Class I	Active
TheraBand, 2.5m, DE Blue – Extra Heavy	13926	EUDAMED	Class I	Active
Theraband, Resistance Tubing With Connectors, Green 24" Set Of 2	21642	EUDAMED	Class I	Active
Theraband, Set of 2 Bands (1 Heavy, 1 X-Heavy), High Resistance Band	14953	EUDAMED	Class I	Active
HYGENIC Dental Dam, 6X6, Green, Hvy, 1/pk Sample	15609	EUDAMED	Class I	Active
HYGENIC Dental Dam 6x6 GREEN MED 36/pk	15499	EUDAMED	Class I	Active
Theraband 25 Yard Non-Latex Blue CE Mark	50354	EUDAMED	Class I	Active
Theraband® Professional Resistance Band 50 Yard Dispenser Red	20130	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