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AMERIWATER LLC.

Last updated September 17, 2026

Information

Country: US
Address: 3345 Stop 8 Rd, DAYTON, OH, 45414
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000515504
DUNS Number: —

Catalogue (46)

Device	Model / Reference	Registries	Class	Status
AmeriWater MRO8Z	MRO8Z	FDA UDI	Class II	Active
AmeriWater Centurion Reverse Osmosis System	00MROC	FDA UDI	Class II	Active
AmeriWater MediQA 00MSP3HF-230	00MSP3HF-230	FDA UDI	Class II	Active
AmeriWater MRO5X	MRO5X	FDA UDI	Class II	Active
AmeriWater 0077-0010 Ozone Disinfection System	0077-0010	FDA UDI	Class II	Active
AmeriWater MediQA 00MSP1-230	00MSP1-230	FDA UDI	Class II	Active
AmeriWater 00BCM55	00BCM55	FDA UDI	Class II	Active
AmeriWater MRO2X	MRO2X	FDA UDI	Class II	Active
AmeriWater MRO3X	MRO3X	FDA UDI	Class II	Active
AmeriWater Water Purification System for Hemodialysis	Complete System	FDA UDI	Class II	Active
AmeriWater MRO4X	MRO4X	FDA UDI	Class II	Active
AmeriWater 00BCM100	00BCM100	FDA UDI	Class II	Active
AmeriWater MRO3Z	MRO3Z	FDA UDI	Class II	Active
AmeriWater Heatsan 00HS208	00HS208	FDA UDI	Class II	Active
AmeriWater MediQA 00MSP2-230	00MSP2-230	FDA UDI	Class II	Active
AmeriWater MRO6Z	MRO6Z	FDA UDI	Class II	Active
AmeriWater MRO2	MRO2	FDA UDI	Class II	Active
AmeriWater MediQA 00MSP3-230	00MSP3-230	FDA UDI	Class II	Active
AmeriWater 00BCMD55	00BCMD55	FDA UDI	Class II	Active
AmeriWater Heatsan 00HS460	00HS460	FDA UDI	Class II	Active
AmeriWater Heatsan 00HS575	00HS575	FDA UDI	Class II	Active
AmeriWater MRO3	MRO3	FDA UDI	Class II	Active
AmeriWater MRO7Z	MRO7Z	FDA UDI	Class II	Active
AmeriWater MROS	MROS	FDA UDI	Class II	Active
AmeriWater 00BC100-200 Bicarb Mix and Distribution System	00BC100-200	FDA UDI	Class II	Active
AmeriWater MediQA 00MDP4-230	00MDP4-230	FDA UDI	Class II	Active
AmeriWater MRO4	MRO4	FDA UDI	Class II	Active
AmeriWater MRO5Z	MRO5Z	FDA UDI	Class II	Active
AmeriWater MediQA 00MDP2-230	00MDP2-230	FDA UDI	Class II	Active
AmeriWater MRO4Z	MRO4Z	FDA UDI	Class II	Active
AmeriWater 00BC55-55 Bicarb Mix and Distribution System	00BC55-55	FDA UDI	Class II	Active
AmeriWater 00BCMD100	00BCMD100	FDA UDI	Class II	Active
AmeriWater 00BC100-100 Bicarb Mix and Distribution System	00BC100-100	FDA UDI	Class II	Active
AmeriWater MRO1	MRO1	FDA UDI	Class II	Active
Modification To Ameriwater Purification System For Hemodialysis	K021560	FDA 510(k)	Class II	Active
AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz	K142285	FDA 510(k)	Class II	Active
Ameriwater Ozone Disinfection System	K141213	FDA 510(k)	Class II	Active
Ameriwater Solution Mix And Distribution System For Hemodialysis	K051031	FDA 510(k)	Class II	Active
Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 To 3 Station	K111740	FDA 510(k)	Class II	Active
AmeriWater MediQA Reverse Osmosis System (MSP3HF)	K223656	FDA 510(k)	Class II	Active
Portable Ro+ Model Mros09	K030059	FDA 510(k)	Class II	Active
Mroz Reverse Osmosis System	K131622	FDA 510(k)	Class II	Active
Ameriwater Centurion 1500+ Reverse Osmosis System With Heat Sanitization	K133783	FDA 510(k)	Class II	Active
Mediqa Single Pass Reverse Osmosis System With Heat Sanitization, Mediqa Double Pass Reverse Osmosis System With Heat Sa	K131904	FDA 510(k)	Class II	Active
Ameriwater Purification System For Hemodialysis	K991519	FDA 510(k)	Class II	Active
Ameriwater Alarm Panel - Base Model And Remote, Base Model & Remote With Conductivity, Base Model & Remote With Resistiv	K121022	FDA 510(k)	Class II	Active

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 9, 2012	Z-2321-2012	—	terminated	The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15 amp fuses instead of 250 volt 15 amp fuses, that was installed in the water system. The incorrect fuse may result in excessive heat in the fuse holder eventually resulting in failure of the device to operate.
Sep 3, 2004	Z-0004-05	—	terminated	The device has a potential risk of failure caused by faulty wiring within the electrical component. The wires can overheat and eventually break in two.