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Bionix, LLC

United States·US-MF-000020408

Last updated September 17, 2026

Information

Country: United States
Address: 1670, Indian Wood Circle, Maumee, United States
Website: www.bionix.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 419 214 6050
PRRC Contact: Joshua Ball
EUDAMED SRN: US-MF-000020408
FDA FEI Number: 1526854
DUNS Number: 117844489

Catalogue (209)

Page 4 of 5

Device	Model / Reference	Registries	Class	Status
Lighted Ear Curette	2204	EUDAMEDFDA UDI	Class I	Active
DeClogger	911	EUDAMEDFDA UDI	Class I	Active
Safe Ear Curettes	3444	EUDAMEDFDA UDI	Class I	Active
Magnification Lens	2265	EUDAMEDFDA UDI	Class I	Active
OtoClear Tips	7200ST	EUDAMEDFDA UDI	Class I	Active
OtoClear Syringe	7235	EUDAMEDFDA UDI	Class I	Active
Radiacare Intraoperative Radiotherapy System	K860606	FDA 510(k)	Class II	Active
Flex-Loop Flexible Ear Corette	K852039	FDA 510(k)	Class I	Active
Lighted Ear Curette	2245	EUDAMEDFDA UDI	Class I	Active
OtoClear SprayWash	7290	EUDAMEDFDA UDI	Class I	Active
Lighted Forceps	2750	EUDAMEDFDA UDI	Class I	Active
DeClogger	922	EUDAMEDFDA UDI	Class I	Active
Lighted Ear Curette	3360	EUDAMEDFDA UDI	Class I	Active
Safe Ear Curettes	1222	EUDAMEDFDA UDI	Class I	Active
Lighted Ear Curette	2207	EUDAMEDFDA UDI	Class I	Active
Lighted Ear Curette	2202	EUDAMEDFDA UDI	Class I	Active
Light Source	2200	EUDAMEDFDA UDI	Class I	Active
OtoClear Tips	7202	EUDAMEDFDA UDI	Class I	Active
Lighted Ear Curette	3330	EUDAMEDFDA UDI	Class I	Active
Lighted Ear Curette	2250	EUDAMEDFDA UDI	Class I	Active
Safe Ear Curettes	4111	EUDAMEDFDA UDI	Class I	Active
DeClogger	912	EUDAMEDFDA UDI	Class I	Active
Lighted Ear Curette	3310	EUDAMEDFDA UDI	Class I	Active
ShotBlocker	8100	EUDAMEDFDA UDI	Class I	Active
OtoClear AquaBot	7270	EUDAMEDFDA UDI	Class I	Active
Safe Ear Curettes	6333	EUDAMEDFDA UDI	Class I	Active
OtoClear Tips	7200	EUDAMEDFDA UDI	Class I	Active
Lighted Ear Curette	2203	EUDAMEDFDA UDI	Class I	Active
Lighted Forceps	2775	EUDAMEDFDA UDI	Class I	Active
Disposable Nasal Speculum	9878	EUDAMEDFDA UDI	Class I	Active
DeClogger	921	EUDAMEDFDA UDI	Class I	Active
OtoClear Ear Irrigation BHH	701	EUDAMEDFDA UDI	Class I	Active
Safe Ear Curettes	9555	EUDAMEDFDA UDI	Class I	Active
OtoClear AquaBot	7275	EUDAMEDFDA UDI	Class I	Active
Safe Ear Curettes	2999	EUDAMEDFDA UDI	Class I	Active
Lighted Ear Curette	3345	EUDAMEDFDA UDI	Class I	Active
Lighted Ear Curette	2209	EUDAMEDFDA UDI	Class I	Active
Lighted Ear Curette	2205	EUDAMEDFDA UDI	Class I	Active
DeClogger	935	EUDAMEDFDA UDI	Class I	Active
OtoClear Ear Irrigation Basin	3700	EUDAMEDFDA UDI	Class I	Active
ShotBlocker	8050	EUDAMEDFDA UDI	Class I	Active
OtoClear SprayWash	7295	EUDAMEDFDA UDI	Class I	Active
Lighted Ear Curette	2280	EUDAMEDFDA UDI	Class I	Active
Lighted Ear Curette	2208	EUDAMEDFDA UDI	Class I	Active
Lighted Ear Curette	2240	EUDAMEDFDA UDI	Class I	Active
Lighted Ear Curette	2260	EUDAMEDFDA UDI	Class I	Active
DeClogger	913	EUDAMEDFDA UDI	Class I	Active
Lighted Ear Curette	2220	EUDAMEDFDA UDI	Class I	Active
Lighted Ear Curette	2201	EUDAMEDFDA UDI	Class I	Active
Safe Ear Curettes	4888	EUDAMEDFDA UDI	Class I	Active

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