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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 2 of 5

Device	Model / Reference	Registries	Class	Status
Bionix Development Corporation	5100	FDA UDI	Class I	Unknown
SafeStraw™ NeoTarget Co-brand	204	FDA UDI	Class I	Unknown
Preemie Transport Blanket	1125	FDA UDI	Class I	Unknown
OtoClear Ear Irrigation System Wands	27220	FDA UDI	Class I	Active
Sample, Safe Ear Curette Rainbow Pack	25777-9	FDA UDI	Class I	Active
SafeStraw™ Drinking Aid for Thick Liquid	212	FDA UDI	Class I	Unknown
SecureVac™ Immobilization System	SVRT-7630	FDA UDI	Class II	Active
Prone Breast, Hardware Kit, Head Rest Carriage, Replacement	PBRT-6303	FDA UDI	Class II	Active
ShotBlocker®	801-SD	FDA UDI	Class I	Unknown
Bionix, LLC	SP-23105	FDA UDI	Class I	Active
ShotBlocker®	08001	FDA UDI	Class I	Unknown
Preemie Hand Splint	1150	FDA UDI	Class I	Unknown
Bionix Development Corporation	SP-20911	FDA UDI	Class II	Active
SafeStraw™ 2 Pack	205	FDA UDI	Class I	Active
ClearLook™ Sample Pack-Curettes Only	23300	FDA UDI	Class I	Active
OtoClear Aquabot Sample	27275	FDA UDI	Class I	Active
Bionix Development Corporation	7280	FDA UDI	Class I	Active
ClearLook Lighted Variety Pack with Rechargeable Light Source	3645	FDA UDI	Class I	Active
Portable WaterPik Adapter Wands	27215	FDA UDI	Class I	Active
IsoMark™ Sample, Black Ink	SP-23101	FDA UDI	Class I	Active
SecureVac Wing Board Cushion	SVRT-7137	FDA UDI	Class II	Active
ClearLook Lighted Variety Pack, Refill	3445	FDA UDI	Class I	Active
Prone Breast, Face Cushion, Replacement	PBRT-6253	FDA UDI	Class II	Active
OtoClear® Spray Wash, Sample	27295	FDA UDI	Class I	Unknown
ClearLook™ Sample Pack-Curettes & Light Source	23301	FDA UDI	Class I	Active
PouchPro	5040	FDA UDI	Class II	Unknown
ClearLook Lighted InfantScoop, Refill	3460	FDA UDI	Class I	Active
Bionix Development Corporation	SP-20912	FDA UDI	Class II	Active
ClearLook Lighted MicroLoop, Refill	3420	FDA UDI	Class I	Active
SafeStraw™ NeoTarget Co-brand	213	FDA UDI	Class I	Unknown
IsoMark™	3101	FDA UDI	Class I	Active
Prone Breast, Hardware Kit, Threaded Indexing Pegs	PBRT-6301	FDA UDI	Class II	Active
SecureVac™ Immobilization System	SVRT-7134	FDA UDI	Class II	Active
SecureVac™ Immobilization System	SVRT-7131	FDA UDI	Class II	Active
Igloo Wound Irrigator	5500	FDA UDI	Class I	Active
ClearLook Lighted VersaLoop, Refill	3430	FDA UDI	Class I	Active
Igloo® Wound Irrigation OTC	601	FDA UDI	Class I	Unknown
OtoClear SprayWash System, Single Use	7291	FDA UDI	Class I	Active
AfterSwim	20530	FDA UDI	Class I	Unknown
Pelvis Belly Plus System	5105-00-03	FDA UDI	Class II	Active
AfterSwim® Water Removal	530-SD	FDA UDI	Class I	Unknown
SecureFoam	25037	FDA UDI	Class II	Active
Lighted Ear Curette Demo Pack	22200	FDA UDI	Class I	Active
Sample: Opti-Tatt	24100	FDA UDI	Class I	Active
Opti-Tatt™ Dots	UTRT-4100	FDA UDI	Class I	Active
SecureFoam	5036	FDA UDI	Class II	Active
SecureFoam	5037	FDA UDI	Class II	Unknown
SecureVac™ Immobilization System	SVRT-7450-A	FDA UDI	Class II	Active
Sample: Opti-Tatt Dots	SP-24100	FDA UDI	Class I	Unknown
Rechargeable Light Source	3600	FDA UDI	Class I	Active

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