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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 5 of 7

Device	Model / Reference	Registries	Class	Status
Theraband, Resistance Tubing with Connectors, Yellow 18” Set of 2	21621	EUDAMED	Class I	Active
HYGENIC Dental Dam 6x6 GREEN Med 360/pk	15501	EUDAMED	Class I	Active
TheraBand, 5’, Black	20263	EUDAMED	Class I	Active
Theraband, 6 Yard, Gold Professional Resistance Band	20080	EUDAMED	Class I	Active
Theraband Int’l High Resistance Band – X- Heavy	15157	EUDAMED	Class I	Active
HYGENIC HR Dental Dam Non-Latex, 6X6, Teal, 1/pk Sample	15616	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 5, Non-Latex, 25M - Black	THA-METBAND25MBLK	EUDAMED	Class I	Active
TheraBand, 2.5m, DE Green - Heavy	13925	EUDAMED	Class I	Active
Theraband, 8’3” (2.5m), Leprello Pack - Black	20264L	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 3, Latex, 1.5M - Green	091191956	EUDAMED	Class I	Active
TheraBand 18” Resistance Band Loop, Gold	15454	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 5, Latex, 1.5M - Black	091191972	EUDAMED	Class I	Active
Theraband, 6 Yard, Yellow Professional Resistance Band	20020	EUDAMED	Class I	Active
Theraband, Accessories Kit	22135	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 4, Latex, 25M - Blue	091259720	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 5, Latex, 46M - Black	091145481	EUDAMED	Class I	Active
TheraBand Exercise Band 2.5m Black in Zipper Bag with Retail Carton - EU	12196	EUDAMED	Class I	Active
TheraBand, 1.5m, DE Yellow - Thin	13918	EUDAMED	Class I	Active
TheraBand, 5’, Red	20232	EUDAMED	Class I	Active
TheraBand 12” Resistance Band Loop, Blue	20841	EUDAMED	Class I	Active
Theraband, 5’ Dispenser Pack, Red	20530	EUDAMED	Class I	Active
TheraBand Exercise Band 2.5m Red in Zipper Bag with Retail Carton - EU	12193	EUDAMED	Class I	Active
TheraBand, 8’3” (2.5m), Green)	20243	EUDAMED	Class I	Active
TheraBand, 2.5m, DE Red - Medium	13924	EUDAMED	Class I	Active
Theraband, Resistance Tubing With Connectors, Red 12" Set Of 2	21630	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 3, Non-Latex, 50M - Green	091338961	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 3, Non-Latex, 1.5M - Green	091191980	EUDAMED	Class I	Active
Theraband, 12”, Multi-color 4 Piece Band Loop Pack (Y, R, GR, BLU) - Latex	14729	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 1, Latex, 1.5M - Red	091181841	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 2, Latex, 46M - Red	091145457	EUDAMED	Class I	Active
Theraband, 50 Yard, Latex Free Yellow CE Mark	11846	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 4, Latex, 5.5M - Blue	091145424	EUDAMED	Class I	Active
Hygenic Trio Dental Dam, 6x6, Med, 3/Pk Sample	15611	EUDAMED	Class I	Active
THERABAND Shoulder Pulley	27313	EUDAMED	Class I	Active
TheraBand Exercise Band 2.5m Blue in Zipper Bag with Retail Carton - EU	12195	EUDAMED	Class I	Active
TheraBand 12” Resistance Band Loop, Silver	15450	EUDAMED	Class I	Active
Theraband, Resistance Bands Light Retail Pack	20403	EUDAMED	Class I	Active
Theraband, 6 Yard, Blue Professional Resistance Band	20050	EUDAMED	Class I	Active
Theraband, Set of 2 Bands (1 Medium, 1 Heavy), High Resistance Band	14952	EUDAMED	Class I	Active
Theraband, 6 Yard, Red Professional Resistance Band	20030	EUDAMED	Class I	Active
International Theraband CLX Bulk 22m (25 Yd) Roll - Blue	12781	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 4, Non-Latex, 50M - Blue	091339027	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 4, Non-Latex, 25M - Blue	091337377	EUDAMED	Class I	Active
THERABAND Wellness Station Assist Strap with "D" ring connector, set of 2	22012	EUDAMED	Class I	Active
Theraband, 50 Yard, Latex Free Blue CE Mark	11849	EUDAMED	Class I	Active
TheraBand 12” Resistance Band Loop, Red	20821	EUDAMED	Class I	Active
TheraBand Exercise Band 2.5m Yellow in Zipper Bag with Retail Carton - EU	12192	EUDAMED	Class I	Active
HYGENIC HR Dental Dam Non-Latex 6x6 Teal 75/pk	15551	EUDAMED	Class I	Active
Theraband, Resistance Tubes, Light Retail Pack	21303	EUDAMED	Class I	Active
Theraband 25 Yard Non-Latex Yellow CE Mark	50324	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