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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 3 of 7

Device	Model / Reference	Registries	Class	Status
Rolyan Exercise Band, Level 2, Latex, 1.5M - Yellow	091191949	EUDAMED	Class I	Active
Theraband, Rehab & Wellness Station	21915	EUDAMED	Class I	Active
Theraband, 8’3” (2.5m), Leprello Pack - Gold	20283L	EUDAMED	Class I	Active
TheraBand 8” Resistance Band Loop, Black	15446	EUDAMED	Class I	Active
TheraBand 8” Resistance Band Loop, Green	20830	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 1, Non-Latex, 25M - Yellow	THA-METBAND25MYEL	EUDAMED	Class I	Active
Theraband, 8" Resistance Band Loop, Silver	15449	EUDAMED	Class I	Active
HYGENIC Dental Dam, 6X6, Green, Thin, 1/pk Sample	15608	EUDAMED	Class I	Active
Theraband Int’l High Resistance Band - Medium	15155	EUDAMED	Class I	Active
Theraband, CLX 9 Loop High Intensity 2-Pack Silver-Gold	15445	EUDAMED	Class I	Active
Hygenic Dental Dam 6x6 Blue Med 36/pk	15530	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 4, Non-Latex, 5M - Blue	091338920	EUDAMED	Class I	Active
Dental Endodontic Cement (modification)	K894092	FDA 510(k)	Class II	Active
Wedjets	K900844	FDA 510(k)	Class I	Active
Tray Dough	K911225	FDA 510(k)	Class I	Active
Gates Glidden Drills	K905418	FDA 510(k)	Class I	Active
Solid Core Gutta Percha Carrier	K905640	FDA 510(k)	Class I	Active
Ultrafil-Lt (gutta Percha)	K850863	FDA 510(k)	Class I	Active
Endo-Ice	K881826	FDA 510(k)	Class II	Active
Pulp Pen	K873644	FDA 510(k)	Class II	Active
Sticky Wax	K854527	FDA 510(k)	Class I	Active
Endocater	K863393	FDA 510(k)	U	Active
Hygenic Rubber Dam Lubricant	K791970	FDA 510(k)	Class I	Active
Endo-Ice-Pulp Tester-Thermal	K930764	FDA 510(k)	Class II	Active
Inlay Wax Regular	K854529	FDA 510(k)	Class I	Active
Novus Bonding Agent	K900301	FDA 510(k)	Class II	Active
Premium Flexi-Tough	K854530	FDA 510(k)	Class I	Active
Theraband, Resistance Tubing with Connectors, Yellow 12”, Set of 2	21620	EUDAMED	Class I	Active
heraband Int’l High Resistance Band - Heavy	15156	EUDAMED	Class I	Active
TheraBand Latex Free Advanced Pack – International	11884	EUDAMED	Class I	Active
THERABAND Wellness Station Extremity Strap with "D" ring connector, set of 2	22141	EUDAMED	Class I	Active
TheraBand, 8’3” (2.5m), Blue	20255	EUDAMED	Class I	Active
HYGENIC FR Dental Dam Non-Latex, 6X6, Purple, 1/pk Sample	15612	EUDAMED	Class I	Active
Rolyan Exercise Band, Level 5, Latex, 5.5M - Black	091145432	EUDAMED	Class I	Active
Theraband, Resistance Tubing with Connectors, Blue 18” Set of 2	21651	EUDAMED	Class I	Active
TheraBand 12” Resistance Band Loop, Gold	15453	EUDAMED	Class I	Active
TheraBand, 2.5m, DE Yellow - Thin	13923	EUDAMED	Class I	Active
International Theraband CLX Bulk 22m (25 Yd) Roll - Yellow	12778	EUDAMED	Class I	Active
Theraband® Professional Resistance Band 50 Yard Dispenser Yellow	20120	EUDAMED	Class I	Active
Theraband, CLX 9 Loop Low Intensity 2-Pack Red-Green	15443	EUDAMED	Class I	Active
THERABAND Elastic Resistance Sports Handle, 12 inch	22125	EUDAMED	Class I	Active
HYGENIC FR Framed Dental Dam Non-Late Purple 20/pk	15514	EUDAMED	Class I	Active
Theraband 25 Yard Non-Latex Gold CE Mark	50384	EUDAMED	Class I	Active
TheraBand, 1.5m, DE Red - Medium	13919	EUDAMED	Class I	Active
Theraband, 50 Yard, Latex Free Green CE Mark	11848	EUDAMED	Class I	Active
Theraband, Resistance Tubing with Connectors, Blue 12” Set of 2	21650	EUDAMED	Class I	Active
Theraband, Extremity Strap with Slide Buckle (Set of 2)	22140	EUDAMED	Class I	Active
heraband, Resistance Tubing Loop with Padded Cuffs, Red	21431	EUDAMED	Class I	Active
International Theraband CLX Bulk 22m (25 Yd) Roll - Black	12782	EUDAMED	Class I	Active
Theraband Door Anchor	22130	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