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OTU MEDICAL INC.

United States·US-MF-000020690

Last updated June 8, 2026

Information

Country: United States
Address: 2847A Whipple Rd, Union City, CA, United States
Website: otumed.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Jingjing Wei
EUDAMED SRN: US-MF-000020690
FDA FEI Number: —
DUNS Number: 100796993

Catalogue (47)

Device	Model / Reference	Registries	Class	Status
WiScope®	OTU-C380SR	FDA UDI	Class II	Active
WiScope®	OTU-A	FDA UDI	Class II	Active
WiScope®	OTU-A	FDA UDI	Class II	Active
WiScope®	OTU-C380RL	FDA UDI	Class II	Active
WiScope®	OTU-C380SL	FDA UDI	Class II	Active
WiScope®	OTU-A	FDA UDI	Class II	Active
WiScope®	OTU-A	FDA UDI	Class II	Active
Aptra	BDCYSD01	FDA UDI	Class II	Active
WiScope®	OTU-C380RR	FDA UDI	Class II	Active
Aptra	BDCYRD01	FDA UDI	Class II	Active
WiScope®	OTU-A	FDA UDI	Class II	Active
WiScope®	OTU-OM100S	FDA UDI	Class II	Active
WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet	K231702	FDA 510(k)	Class II	Active
WiScope Digital Endoscope System	K181977	FDA 510(k)	Class II	Active
WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System	K210579	FDA 510(k)	Class II	Active
WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System	K220399	FDA 510(k)	Class II	Active
WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System	K212202	FDA 510(k)	Class II	Active
WiScope	OTU-BR02	EUDAMEDFDA UDI	Class IIa	Active
WiScope	OTU-BR03	EUDAMEDFDA UDI	Class IIa	Active
Aptra	BDRD01	EUDAMEDFDA UDI	Class IIa	Active
WiScope	OTU-BR01	EUDAMEDFDA UDI	Class IIa	Active
WiScope	OTU-120R	EUDAMEDFDA UDI	Class IIa	Active
WiScope	OTU-HY02S	EUDAMED	Class IIa	Active
WiScope	OTU-C330R	EUDAMED	Class IIa	Active
WiScope	OTU-100SR	EUDAMEDFDA UDI	Class IIa	Active
Aptra	BDSD01	EUDAMEDFDA UDI	Class IIa	Active
Aptra	BDVP01	EUDAMEDFDA UDI	Class I	Active
WiScope	OTU-HY02C	EUDAMED	Class IIa	Active
WiScope	OTU-C380RR	EUDAMED	Class IIa	Active
WiScope	OTU-OM100SR	EUDAMEDFDA UDI	Class IIa	Active
WiScope	OTU-OM100RR	EUDAMEDFDA UDI	Class IIa	Active
WiScope	OTU-A	EUDAMEDFDA UDI	Class I	Active
WiScope	OTU-T	EUDAMEDFDA UDI	Class I	Active
WiScope	OTU-HY04C	EUDAMED	Class IIa	Active
WiScope	OTU-RL01	EUDAMED	Class IIa	Active
WiScope	OTU-C300S	EUDAMEDFDA UDI	Class IIa	Active
WiScope	OTU-C300R	EUDAMEDFDA UDI	Class IIa	Active
WiScope	OTU-RL02	EUDAMED	Class IIa	Active
WiScope	OTU-OM100R	EUDAMEDFDA UDI	Class IIa	Active
WiScope	OTU-T	EUDAMEDFDA UDI	Class I	Active
WiScope	OTU-C311S	EUDAMEDFDA UDI	Class IIa	Active
WiScope	OTU-100RR	EUDAMEDFDA UDI	Class IIa	Active
WiScope	OTU-C310R	EUDAMEDFDA UDI	Class IIa	Active
WiScope	OTU-C311R	EUDAMEDFDA UDI	Class IIa	Active
WiScope	OTU-100RL	EUDAMEDFDA UDI	Class IIa	Active
WiScope	OTU-OM100RL	EUDAMEDFDA UDI	Class IIa	Active
WiScope	OTU-C380RL	EUDAMEDFDA UDI	Class IIa	Active

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