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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 2 of 7

Device	Model / Reference	Registries	Class	Status
Theraband, Tubing with Soft Handles, Yellow	21731	EUDAMED	Class I	Active
Cramer International Underwrap 2.75” x 30yds 48pk - Green	414630	EUDAMED	Class I	Active
Theraband, Tubing with Flexible Handles, Green	21743	EUDAMED	Class I	Active
Cramer Cover-All Tape, 2" x 10yd, EA	15459	EUDAMED	Class I	Active
Theraband, Tubing with Hard Handles, Blue	21704	EUDAMED	Class I	Active
Theraband, Tubing with Soft Handles, Green	21723	EUDAMED	Class I	Active
Theraband, Tubing with Soft Handles, Red	21732	EUDAMED	Class I	Active
Theraband, Tubing with Soft Handles, Blue	21724	EUDAMED	Class I	Active
Theraband, Tubing with Soft Handles, Black	21725	EUDAMED	Class I	Active
Cramer International Underwrap 2.75” x 30yds 48pk - Blue)	414610	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 2, Latex, 30.5M - Red	091170349	EUDAMED	Class I	Active
Cramer Cover-All Tape Retail, 2” x 10yds x12 Rolls	15487	EUDAMED	Class I	Active
Rolyan Exercise Tubing, Level 1, Latex, 30.5M - Yellow	THA-METTUB100YELL	EUDAMED	Class I	Active
Theraband, Tubing with Hard Handles, Black	21705	EUDAMED	Class I	Active
Theraband, Tubing 100’ Box w/ CE Mark, Yellow	51120	EUDAMED	Class I	Active
Theraband, Tubing with Hard Handles, Green	21702	EUDAMED	Class I	Active
Rolyan O-Ring Exerciser, X-Extra Firm - Black	THA-PHYORINGBLK	EUDAMED	Class I	Active
Theraband, Tubing 25’ Box w/ CE Mark, Green	51040	EUDAMED	Class I	Active
Theraband, Tubing 25’ Box w/ CE Mark, Blue	51050	EUDAMED	Class I	Active
Theraband, Tubing 25’ Box w/ CE Mark, Red	51030	EUDAMED	Class I	Active
Theraband, Tubing with Hard Handles, Red	21702	EUDAMED	Class I	Active
HYGENIC FR FRAMED Dental Dam Non-Latex, Purple 1/pk Sample	15615	EUDAMED	Class I	Active
EU Theraband CLX Individual 11 Loops Pre-Cut Silver	13224	EUDAMED	Class I	Active
TheraBand Red Non-Latex Tubing 100 ft	15493	EUDAMED	Class I	Active
EU Theraband CLX Individual 11 Loops Pre-Cut Blue	13222	EUDAMED	Class I	Active
HYGENIC FR Dental Dam Non-latex 6x6 GREEN 30/PK	15483	EUDAMED	Class I	Active
Polodent Framed Dental Dam Non-Latex, Purple 20/Pk	15603	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 2, Non-Latex, 25M - Red	091337351	EUDAMED	Class I	Active
Theraband, Set of 2 Bands (1 Light, 1 Medium), High Resistance Band	14951	EUDAMED	Class I	Active
Sammons Preston 5' Multi Color 5 Piece Band Pack Non- Latex	15430	EUDAMED	Class I	Active
Theraband, 5’ Dispenser Pack, Yellow	20520	EUDAMED	Class I	Active
HYGENIC Dental Dam 6x6 GREEN Hvy 36/pk	15500	EUDAMED	Class I	Active
EU Theraband CLX Individual 11 Loops Pre-Cut Yellow	13219	EUDAMED	Class I	Active
Theraband, 6 Yard, Silver Professional Resistance Band	20070	EUDAMED	Class I	Active
Theraband 25 Yard Non-Latex Black CE Mark	50364	EUDAMED	Class I	Active
Theraband, Resistance Tubing With Connectors, Green 18" Set Of 2	21641	EUDAMED	Class I	Active
Theraband, Exercise Station	21900	EUDAMED	Class I	Active
HYGENIC Dental Dam 5x5 GREEN Med 52/pk	15502	EUDAMED	Class I	Active
Theraband, Resistance Tubing with Connectors, Yellow 24” Set of 2	21622	EUDAMED	Class I	Active
Theraband 25 Yard Non-Latex Silver CE Mark	50374	EUDAMED	Class I	Active
Theraband, 8’3” (2.5m), Leprello Pack - Red	20234L	EUDAMED	Class I	Active
Theraband® Professional Resistance Band 50 Yard Dispenser Tan	20110	EUDAMED	Class I	Active
International Theraband CLX Bulk 22m (25 Yd) Roll - Gold	12784	EUDAMED	Class I	Active
HYGENIC FR 6x6 Dental Dam Non-latex PURPLE 30-PC/BX	15482	EUDAMED	Class I	Active
HYGENIC Trio Dental Dam 6x6 Med 36/pk	15547	EUDAMED	Class I	Active
Theraband, Resistance Tubing With Connectors, Red 18" Set Of 2	21631	EUDAMED	Class I	Active
TheraBand, 1.5m, DE Green - Heavy	13920	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 5, Non-Latex, 25M - Black	091337385	EUDAMED	Class I	Active
Theraband® Professional Resistance Band 50 Yard Dispenser Green	20140	EUDAMED	Class I	Active
TheraBand 18” Resistance Band Loop, Blue	20842	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