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Otodynamics

Last updated May 23, 2026

Information

Country: US
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Catalogue (206)

Page 4 of 5

Device	Model / Reference	Registries	Class	Status
Tip Sample Box (Neonate)	NEO-BOX	FDA UDI	Class II	Active
Otoport/Otocheck Case service kit	OP-CASE-KIT	FDA UDI	Class II	Active
N4C Tips PK100	T-N4C	FDA UDI	Class II	Active
Otoport/Otocheck Charging Cradle	OCC	FDA UDI	Class II	Active
UGD TE+DPOAE Serviceable Probe (BLUE)	PR-ABRLD	FDA UDI	Class II	Active
SGS TEOAE General (UGS probe with 8-pin probe adaptor)	PR-SGS-5	FDA UDI	Class II	Active
Otoport Pro OAE instrument	OPRO-O	FDA UDI	Class II	Active
DPOAE probe tips	T-R11M	FDA UDI	Class II	Active
BGS Body & Lid for UGS ECP and SGS probe	BGS	FDA UDI	Class II	Active
General Tip Holder for X-series Probes PK25	GTH-25	FDA UDI	Class II	Active
Echoport USB Amplifier PCB	EP-AMP-KIT	FDA UDI	Class II	Active
Tip Sample Box (General)	GEN-BOX	FDA UDI	Class II	Active
Otocheck - TEOAE Screener	OC-ST	FDA UDI	Class II	Active
Otolink PC Software Suite	OTOLINK	FDA UDI	Class II	Active
OtoNova Pro User Manual	MANNPRO	FDA UDI	Class II	Active
Probe Pouch	PR-POUCH	FDA UDI	Class II	Active
Probe Cable Clip	PR-CLIP	FDA UDI	Class II	Active
OtoNova Pro Clinical+AABR	NPRO-CLN-DA	FDA UDI	Class II	Active
ABR PSU PCB service kit	ABR-PSU-KIT	FDA UDI	Class II	Active
TEOAE probe tips	T-T8M	FDA UDI	Class II	Active
Echoport Carry Bag	EP-BAG	FDA UDI	Class II	Active
ABR Case service kit - Bottom	ABR-CBOT-KIT	FDA UDI	Class II	Active
ABR Starter Pack	ABR-SK	FDA UDI	Class II	Active
TEOAE probe tips	T-T11M	FDA UDI	Class II	Active
DPOAE probe tips	T-R6.8B	FDA UDI	Class II	Active
UGD/UPD Probe Body & Lid (BLUE) PK 10	BGDL	FDA UDI	Class II	Active
Otoport Pro Case service kit (Barcode)	OP2-CASE-KIT-B	FDA UDI	Class II	Active
Otoport Mini Printer V2 package	OPRO-PP	FDA UDI	Class II	Active
Electrode Cable 2m	ABR-EC2	FDA UDI	Class II	Active
OtoNova Pro Screener DP	NPRO-SCR-D	FDA UDI	Class II	Active
XPD Ear Probe	PR-XPD	FDA UDI	Class II	Active
ABR Case service kit – latch locking	ABR-LOCK-KIT	FDA UDI	Class II	Active
Otocheck - ABR Screener	OC-ABR	FDA UDI	Class II	Active
Otoport Pro Screener AABR	OPRO-SCR-A	FDA UDI	Class II	Active
Red/Blue (Right/Left ear) ID labels/sleeves for XPD probe	XPD-RL	FDA UDI	Class II	Active
Otoport Keypad PCB Assembly	OP-KEY-KIT	FDA UDI	Class II	Active
Tab Electrode Cable 2m	ABR-EC2-T	FDA UDI	Class II	Active
Otoport/Otocheck Mini Printer (supplied with system)	OMP	FDA UDI	Class II	Active
Echoport Socket & Loom Assembly	EP-SOCK-KIT	FDA UDI	Class II	Active
ABR Amplifier & Control service kit	ABR-AMP-KIT	FDA UDI	Class II	Active
Otoport Pro LCD Service Kit	OP2-SCRN-KIT	FDA UDI	Class II	Active
BND Body & Lid for SND probe	BND	FDA UDI	Class II	Active
Otoport/Otocheck Infection Control Sleeve	OP-INF	FDA UDI	Class II	Active
ABR Test Cavity	ABR-CAV	FDA UDI	Class II	Active
Otoport Pro User Manual - English	MANABR6	FDA UDI	Class II	Active
OtoNova Pro Screener DP+TE	NPRO-SCR-DT	FDA UDI	Class II	Active
TEOAE probe tips	T-T7M	FDA UDI	Class II	Active
BNS Body & Lid for SNS probe	BNS	FDA UDI	Class II	Active
Otoport Analogue PCB service kit	OP-ANALOG-KIT	FDA UDI	Class II	Active
Otoport V2/Pro Fabric Carry Case	OPRO-CAS	FDA UDI	Class II	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

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