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US
Last updated May 23, 2026
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Catalogue (206)
Page 2 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TPC Couplers Couplers | TPC-100 | FDA UDI | Class II | Active |
| DPOAE probe tips | T-R5.8B | FDA UDI | Class II | Active |
| UGS TEOAE General Purpose Probe | PR-UGS | FDA UDI | Class II | Active |
| DPC Couplers Couplers | DPC-10 | FDA UDI | Class II | Active |
| UGD/UPD Probe Body & Lid (RED) PK 10 | BGDR | FDA UDI | Class II | Active |
| TEOAE probe tips | T-T13M | FDA UDI | Class II | Active |
| UGS TEOAE General Purpose Probe | PR-UGD | FDA UDI | Class II | Active |
| N3.6C Tips PK100 | T-N3.6C | FDA UDI | Class II | Active |
| OAE Test Cavity | OAE-CAV | FDA UDI | Class II | Active |
| Otoport/Otocheck Min-Printer Self-Adhesive Paper Rolls (supplied with system) | OMP-SA-PAP | FDA UDI | Class II | Active |
| Crib/bassinet device holster for OtoNova | NOVA-CRIB | FDA UDI | Class II | Active |
| ABR Electrode Cable V2 (TAB) for Otoport V2/Pro | OPRO-TEC | FDA UDI | Class II | Active |
| OtoNova Pro Screener DP+TE+AABR | NPRO-SCR-DTA | FDA UDI | Class II | Active |
| FOAM large DPOAE probe tips | T-R100L | FDA UDI | Class II | Active |
| OtoNova Pro Fabric Carry Case | NPRO-CAS | FDA UDI | Class II | Active |
| Echoport Case service kit | EP-CASE-KIT | FDA UDI | Class II | Active |
| TEOAE probe tips | T-T4.5C | FDA UDI | Class II | Active |
| N4.5C Tips PK100 | T-N4.5C | FDA UDI | Class II | Active |
| Calibration Unit | CAL-UNIT | FDA UDI | Class II | Active |
| Otoport Battery Assembly service kit | OP-BATT-KIT | FDA UDI | Class II | Active |
| N5C Tips PK100 | T-N5C | FDA UDI | Class II | Active |
| UGS/UPS Probe Body & Lid (BLUE) PK 10 | BGSL | FDA UDI | Class II | Active |
| TE Tip Sample Box | TE-BOX | FDA UDI | Class II | Active |
| Otocheck - TEOAE+ABR Screener | OC-ST+ABR | FDA UDI | Class II | Active |
| Otoport V2/Pro Fabric Case (with Printer compartment) | OPRO-PCAS | FDA UDI | Class II | Active |
| Otoport Pro OAE+AABR instrument | OPRO-O+A | FDA UDI | Class II | Active |
| DPOAE probe tips | T-R9M | FDA UDI | Class II | Active |
| UGS/UPS Probe Body & Lid (RED) PK 10 | BGSR | FDA UDI | Class II | Active |
| Otoport DP Clinical | CLN-SD | FDA UDI | Class II | Active |
| TEOAE probe tips | T-T3E | FDA UDI | Class II | Active |
| SGS TEOAE General (UGS probe with 5-pin probe adaptor) | PR-SGS-8 | FDA UDI | Class II | Active |
| SNS TEOAE Newborn (UGS probe with 8-pin probe adaptor) | PR-SNS-8 | FDA UDI | Class II | Active |
| OtoNova Pro Screener TE | NPRO-SCR-T | FDA UDI | Class II | Active |
| Otoport Pro Clinical+TE | OPRO-CLN-DT | FDA UDI | Class II | Active |
| ABR Electrode Cable V2 (SNAP) for Otoport V2/Pro | OPRO-SEC | FDA UDI | Class II | Active |
| OtoNova Pro Screener TE+AABR | NPRO-SCR-TA | FDA UDI | Class II | Active |
| DPOAE probe tips | T-R13M | FDA UDI | Class II | Active |
| TEOAE probe tips | T-T6.5B | FDA UDI | Class II | Active |
| OtoNova Pro Clinical+TE | NPRO-CLN-DT | FDA UDI | Class II | Active |
| USB Cable 2m | USB-CAB-2 | FDA UDI | Class II | Active |
| Tab Electrode Cable 1m | ABR-EC1-T | FDA UDI | Class II | Active |
| Otoport - DP+TE OAE+ABR Analyser | DTC-S+ABR | FDA UDI | Class II | Active |
| Otoport/Otocheck Docking Station | ODS-R | FDA UDI | Class II | Active |
| TPC Couplers Couplers | TPC-10 | FDA UDI | Class II | Active |
| ABR Electrode Cable (TAB) for OtoNova Pro | NPRO-TEC | FDA UDI | Class II | Active |
| Otoport/Otocheck Mini-Printer Cable | OMP-CAB-R | FDA UDI | Class II | Active |
| DPOAE probe tips | T-R7M | FDA UDI | Class II | Active |
| Otoport - ABR module (upgrade) | ABR-UG | FDA UDI | Class II | Active |
| Otoport Keypad Mat | OP-KPAD-KIT | FDA UDI | Class II | Active |
| OtoNova Charger | NOVA-CHG | 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