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Abmrc LLC

United States·US-MF-000012891

Last updated September 17, 2026

Information

Country: United States
Address: 860 Blue Gentian Road, Suite 200, Eagan, Minnesota, United States
Website: www.abmrc.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1-877-226-7201
PRRC Contact: Priyanka Paul
EUDAMED SRN: US-MF-000012891
FDA FEI Number: 3016774528
DUNS Number: 033900786

Catalogue (18)

Device	Model / Reference	Registries	Class	Status
BiWaze Two Step Adapter	BK1443	EUDAMED	Class I	Active
BiWaze Clear System	BK181	FDA UDI	Class II	Active
BiWaze Cough Dual Lumen Circuit With Mouthpiece	BC23387	FDA UDI	Class II	Active
BiWaze Clear Dual Lumen Circuit With Face Mask - Child	BK291	FDA UDI	Class II	Active
BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Large	BC23418	FDA UDI	Class II	Active
BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Small	BK289	FDA UDI	Class II	Active
BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Medium	BC23412	FDA UDI	Class II	Active
BiWaze Cough	203735181820113	FDA UDI	Class II	Active
BiWaze Clear Dual Lumen Circuit With Trach Adapter	BK293	FDA UDI	Class II	Active
BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Large	BK285	FDA UDI	Class II	Active
BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Small	BC23406	FDA UDI	Class II	Active
BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Medium	BK287	FDA UDI	Class II	Active
BiWaze Cough Dual Lumen Circuit With Trach Adapter	BC23394	FDA UDI	Class II	Active
BiWaze Cough Dual Lumen Circuit With Face Mask - Child	BC23400	FDA UDI	Class II	Active
BiWaze Clear Dual Lumen Circuit With Mouthpiece	BK280	FDA UDI	Class II	Active
BiWaze Clear System	K231728	EUDAMEDFDA 510(k)	Class II	Active
BiWaze Clear System	K213564	FDA 510(k)	Class II	Active
BiWaze Cough	2037351818-21406	EUDAMED	Class IIa	Active

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