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Otodynamics

Last updated May 23, 2026

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Country: US
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Catalogue (206)

Page 3 of 5

Device	Model / Reference	Registries	Class	Status
ECP Echocheck General Purpose Probe	PR-ECP	FDA UDI	Class II	Active
OtoNova Pro Charger PCB Service Kit	ON2-CHG-KIT	FDA UDI	Class II	Active
Otoport/Otocheck Carry Case with Printer	OPP-CAS	FDA UDI	Class II	Active
OtoNova Pro Clinical+TE+AABR	NPRO-CLN-DTA	FDA UDI	Class II	Active
OtoNova Pro Screener DP+AABR	NPRO-SCR-DA	FDA UDI	Class II	Active
Otoport/Otocheck Min-Printer Self-Adhesive Paper Rolls	OMP-SA-PAP-R	FDA UDI	Class II	Active
TE DPOAE Box Sample Box	TE-DP-BOX	FDA UDI	Class II	Active
UGS TEOAE Serviceable Probe (RED)	PR-ABRRS	FDA UDI	Class II	Active
Otoport Pro Display Window service item	OP2-WIN	FDA UDI	Class II	Active
ABR Fixing Screw	ABR-SCR	FDA UDI	Class II	Active
EZ-Screen Software	EZ-Screen	FDA UDI	Class II	Active
OtoNova Pro Case Service Kit	ON2-CASE-KIT	FDA UDI	Class II	Active
Otoport/Otocheck compact wired charger (Locking connector)	OP-CHG-LOCK	FDA UDI	Class II	Active
Otoport ABR Binaural Upgrade Kit (TE)	BINAURAL-KIT-TE	FDA UDI	Class II	Active
Otoport/Otocheck compact wired charger	OP-CHG	FDA UDI	Class II	Active
Otocheck - DPOAE + ABR Screener	OC-SD+ABR	FDA UDI	Class II	Active
N6.5B Tips PK100	T-N6.5B	FDA UDI	Class II	Active
Otoport LCD service kit	OP-SCRN-KIT	FDA UDI	Class II	Active
ABR Electrode Cable (SNAP) for OtoNova Pro	NPRO-SEC	FDA UDI	Class II	Active
ABR Case service kit – latch non locking	ABR-NLOC-KIT	FDA UDI	Class II	Active
Otoport Pro Main PCB Assembly, service item	OP2-MAIN	FDA UDI	Class II	Active
Otoport Pro Screener DP+TE+AABR	OPRO-SCR-DTA	FDA UDI	Class II	Active
Otoport - DP+TE OAE Analyser	DTC-S	FDA UDI	Class II	Active
Otoport Pro Clinical+AABR	OPRO-CLN-DA	FDA UDI	Class II	Active
ABR Ear Cups	ABR-CUP-R	FDA UDI	Class II	Active
SND TE+DPOAE Newborn (UGD probe with 8-pin probe adaptor)	PR-SND	FDA UDI	Class II	Active
Echoport Main PCB	EP-MAIN	FDA UDI	Class II	Active
ABR Electrode Cable V2 (NHSP) for Otoport V2/Pro	OPRO-NEC	FDA UDI	Class II	Active
Electrode Cable 1m	ABR-EC1	FDA UDI	Class II	Active
ABR Case service kit - Top	ABR-CTOP-KIT	FDA UDI	Class II	Active
Otoport ABR Binaural Upgrade Kit (DP)	BINAURAL-KIT-DP	FDA UDI	Class II	Active
Otoport Charger V2	OPRO-CHG	FDA UDI	Class II	Active
OtoNova Pro Infection Control Sleeve	NPRO-INF	FDA UDI	Class II	Active
OtoNova Pro Main PCB Service Kit	ON2-MAIN	FDA UDI	Class II	Active
FOAM small DPOAE probe tips	T-R100S	FDA UDI	Class II	Active
Otoport/Otocheck Mini-Printer Cable (supplied with system)	OMP-CAB	FDA UDI	Class II	Active
Equipment Case for OAE+ABR Kit	ABR-CAS	FDA UDI	Class II	Active
Otoport Pro AABR instrument	OPRO-A	FDA UDI	Class II	Active
ILOv6 Software	ILOv6	FDA UDI	Class II	Active
Otoport - ABR Screener	OS-ABR	FDA UDI	Class II	Active
FOAM small TEOAE probe tips	T-T200S	FDA UDI	Class II	Active
Otoport Pro Screener TE+AABR	OPRO-SCR-TA	FDA UDI	Class II	Active
Otoport/Otocheck Min-Printer Paper Rolls	OMP-PAP-R	FDA UDI	Class II	Active
Otoport Pro Screener DP+TE	OPRO-SCR-DT	FDA UDI	Class II	Active
Otoport Pro Docking Station	OPRO-DS	FDA UDI	Class II	Active
Otoport Connector PCB Assembly service kit	OP-CONN-KIT	FDA UDI	Class II	Active
Otoport Main PCB Assembly	OP-MAIN	FDA UDI	Class II	Active
Otoport Pro Clinical	OPRO-CLN-D	FDA UDI	Class II	Active
Otoport Pro Advanced Clinical+AABR	OPRO-ADV-DTA	FDA UDI	Class II	Active
ABR OAE Probe Interface PCB service kit	ABR-INT-KIT	FDA UDI	Class II	Active

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FDA Establishments (1)

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Otodynamics, Ltd. HATFIELD, HERTS Hertfordshire · GB FEI 2939