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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 1 of 7

Device	Model / Reference	Registries	Class	Status
Theraband, Tubing with Soft Handles, Silver	21736	EUDAMED	Class I	Active
Theraband, Tubing 100’ Box w/ CE Mark, Green	51140	EUDAMED	Class I	Active
Theraband, Tubing with Flexible Handles, Yellow	21741	EUDAMED	Class I	Active
Theraband, Tubing with Flexible Handles, Silver	21746	EUDAMED	Class I	Active
Cramer International Underwrap 2.75” x 30yds 48pk - Orange	414635	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 1, Latex, 30.5M - Yellow	091170323	EUDAMED	Class I	Active
Rolyan Figure 8 Exerciser, X-Extra Firm - Black	THA-PHYFIG8BLK	EUDAMED	Class I	Active
Rolyan Exercise Tubing, Level 5, Latex, 30.5M - Black	THA-METTUB100BLK	EUDAMED	Class I	Active
Cramer ULTRALASTIC Tear Stretch Tape, 2"x7.5yds, White	7033181	EUDAMED	Class I	Active
Theraband, 25’ CE Mark Tubing Box, Tan	51010	EUDAMED	Class I	Active
Theraband, Tubing with Soft Handles, Black	21735	EUDAMED	Class I	Active
Theraband, Tubing 25’ Box w/ CE Mark, Yellow	51020	EUDAMED	Class I	Active
Theraband, Tubing with Soft Handles, Green	21733	EUDAMED	Class I	Active
Cramer ULTRALASTIC Tear Stretch Tape, 3"x7.5yds, Black	7033184	EUDAMED	Class I	Active
Theraband, Tubing 100’ Box w/ CE Mark, Red	51130	EUDAMED	Class I	Active
Rolyan Exercise Tubing, Level 4, Latex, 100ft - Blueberry	081157080	EUDAMED	Class I	Active
Theraband, Tubing 100’ Box w/ CE Mark, Silver	51170	EUDAMED	Class I	Active
Rolyan Exercise Tubing, Level 3, Latex, 30.5M - Green	THA-METTUB100GRN	EUDAMED	Class I	Active
Rolyan Exercise Tubing, Level 1, Latex, 100ft - Lemon	081157056	EUDAMED	Class I	Active
Theraband, Tubing with Soft Handles, Blue	21734	EUDAMED	Class I	Active
Cramer ULTRALASTIC Tear Stretch Tape, 3"x7.5yds, White	7033182	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 4, Latex, 30.5M - Blue	91170380	EUDAMED	Class I	Active
Cramer International Underwrap 2.75” x 30yds 48pk - Black	414615	EUDAMED	Class I	Active
Theraband, Tubing with Flexible Handles, Blue	21744	EUDAMED	Class I	Active
Theraband, Tubing with Hard Handles, Silver	21706	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 5, Latex, 30.5M - Black	091170406	EUDAMED	Class I	Active
Cramer Non-Tear Stretch Tape, 2”x5yds, Beige, Intnl	484230	EUDAMED	Class I	Active
Cramer Cover-All Tape, 4" x 10yd, EA	15460	EUDAMED	Class I	Active
Theraband, Tubing 100’ Box w/ CE Mark, Blue	51150	EUDAMED	Class I	Active
Rolyan Exercise Tubing, Level 2, Latex, 100ft - Orange	081157064	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 3, Latex, 30.5M - Green	091170364	EUDAMED	Class I	Active
Cramer International Underwrap 2.75” x 30yds 48pk - Beige	414592	EUDAMED	Class I	Active
Cramer Cover-All Tape Retail, 4” x 10yds x12 Rolls	15488	EUDAMED	Class I	Active
Theraband, Tubing 25’ Box w/ CE Mark, Silver	51070	EUDAMED	Class I	Active
Cramer ULTRALASTIC Tear Stretch Tape, 2"x7.5yds, Black	7033183	EUDAMED	Class I	Active
Theraband, Tubing with Soft Handles, Yellow	21721	EUDAMED	Class I	Active
Theraband, Tubing with Flexible Handles, Red	21742	EUDAMED	Class I	Active
Rolyan Figure 8 Exerciser, Firm - Green	THA-PHYFIG8GRN	EUDAMED	Class I	Active
Rolyan Exercise Tubing, Level 2, Latex, 30.5M - Red	THA-METTUB100RED	EUDAMED	Class I	Active
Rolyan Exercise Tubing, Level 5, Latex, 100ft - Plum	081157098	EUDAMED	Class I	Active
Rolyan Exercise Tubing, Level 3, Latex, 100ft - Lime	081157072	EUDAMED	Class I	Active
THERABAND FlexBar Resistive Exerciser, Yellow	26107	EUDAMED	Class I	Active
THERABAND® Comfort Fit Ankle/Wrist Weight Green 3 lb. Pair (1.5 lb. each)	25871	EUDAMED	Class I	Active
Int’l THERABAND® Pro Series SCP™ Exercise Ball - 55 cm Red (display packaging)	12041	EUDAMED	Class I	Active
Theraband, Tubing with Soft Handles, Red	21722	EUDAMED	Class I	Active
Rolyan 2oz Therapy Putty – Medium Soft Red)	081029545	EUDAMED	Class I	Active
Cramer Rigidguard Tape Retail, 1.5” x 15yds	15486	EUDAMED	Class I	Active
Cramer 1050i Athletic Sports Tape, 1.5”x15yds, White, Intnl	481050	EUDAMED	Class I	Active
Theraband, Tubing with Soft Handles, Silver	21726	EUDAMED	Class I	Active
Theraband, Tubing with Flexible Handles, Black	21745	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