Sentiero Advanced NavPRO ONE

FDA UDI

Class II (US FDA UDI)

by PATH medical GmbH

Identity

Trade Name: Sentiero Advanced NavPRO ONE FDA UDI
Generic Name: Evoked-potential audiometer FDA UDI
Device Name: Sentiero NavPRO ONE Set: Content: 1. Sentiero Advance device AN100360-NPO 2. Carrying case AN100928 3. Inlay AN100677 4. Insert Earphone PIEP Bio-Logic AN100860-BL 5. Bone Conductor B81 AN100888 or B71W AN100344 optionally 6. Electrode Trunk Cable AN100881 7. Electrode Lead Cable AN100891-1 8. Electrodes AN100468 9. ABR Software AN100337 10. ABR Binaural Software AN100424 11. ABR FFC Software AN100466 12. ECochG Software AN100464 13. Software label printer AN100414 14. PC Patient Management Software AN100116 15. USB data cable AN100089 16. USB stick Bio-Logic AN100724-BL 17. Power supply Sentiero Advanced US AN100268-US 18. Manual Bio-Logic AN100904-EN-BL FDA UDI
Model / Reference: 8-04-16550 FDA UDI
Description: Sentiero NavPRO ONE Set: Content: 1. Sentiero Advance device AN100360-NPO 2. Carrying case AN100928 3. Inlay AN100677 4. Insert Earphone PIEP Bio-Logic AN100860-BL 5. Bone Conductor B81 AN100888 or B71W AN100344 optionally 6. Electrode Trunk Cable AN100881 7. Electrode Lead Cable AN100891-1 8. Electrodes AN100468 9. ABR Software AN100337 10. ABR Binaural Software AN100424 11. ABR FFC Software AN100466 12. ECochG Software AN100464 13. Software label printer AN100414 14. PC Patient Management Software AN100116 15. USB data cable AN100089 16. USB stick Bio-Logic AN100724-BL 17. Power supply Sentiero Advanced US AN100268-US 18. Manual Bio-Logic AN100904-EN-BL FDA UDI

Identifiers

Catalog Number: 100340-BL-US1 FDA UDI
Primary DI / UDI-DI: 04260223143526 FDA UDI
FDA Product Code: GWJ FDA UDI
EWO FDA UDI
GMDN Term: Evoked-potential audiometer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1900 FDA UDI
874.1050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Evoked-potential audiometer

Sentiero Advanced NavPRO ONE by PATH medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Evoked-potential audiometer.

ECochG Adapters — Vivosonic Inc · Class II
TE Tip Sample Box — Otodynamics · Class II
Tip Sample Box (Neonate) — Otodynamics · Class II
Otoport LCD service kit — Otodynamics · Class II
TEOAE probe tips — Otodynamics · Class II
ABR Case service kit - Top — Otodynamics · Class II
Otoport ABR Binaural Upgrade Kit (TE) — Otodynamics · Class II
ABR Test Cavity — Otodynamics · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: PATH medical GmbH

Sources (1)

FDA UDI c1f130fc-8086-433e-a62a-47e586cb815f 34 fields · synced Jun 8, 2026