Sentiero Advanced

FDA UDI

Class II (US FDA UDI)

by PATH medical GmbH

Identity

Trade Name: Sentiero Advanced FDA UDI
Generic Name: Evoked-potential audiometer FDA UDI
Device Name: Sentiero Advanced ABR, OAE, Tympanometry and Audio Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Path electrodes: 30 pcs. / bag. Each bag contains 10 sets of 3 pcs. AN 100468 5. Sentiero Advanced device with touchscreen AN100360 6. ABR electrode cable AN100307 7. Headphone DD-45 AN100306 8. Probe EP-LT AN101021 9. Accessory box EP-LT AN101043 10. ABR Quick SW AN100337-Quick 11. TEOAE Quick SW AN100109-Quick 12. DPOAE Quick SW AN100110-Quick 13. FMDPOAE SW AN100536 14. Tymp Class 2 SW AN100560 15. Audio Class 4 Advanced SW AN100653 16. Mira PC Patient Management SW AN100116 17. Label Printer SW AN100414 18. Power Supply Sentiero Advanced US AN101016+AN100993-USA 19. Tympanometry add-on TY-MA AN100947 20. Accessory box AB08 AN100734-P 21. Tympanometry cavity AN100549 22. Probe tip small PT-S AN100014-W (3 pcs.) 23. Probe tip medium PT-A AN100013 (5 pcs.) FDA UDI
Model / Reference: 100340-SC-ALL-LT FDA UDI
Description: Sentiero Advanced ABR, OAE, Tympanometry and Audio Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Path electrodes: 30 pcs. / bag. Each bag contains 10 sets of 3 pcs. AN 100468 5. Sentiero Advanced device with touchscreen AN100360 6. ABR electrode cable AN100307 7. Headphone DD-45 AN100306 8. Probe EP-LT AN101021 9. Accessory box EP-LT AN101043 10. ABR Quick SW AN100337-Quick 11. TEOAE Quick SW AN100109-Quick 12. DPOAE Quick SW AN100110-Quick 13. FMDPOAE SW AN100536 14. Tymp Class 2 SW AN100560 15. Audio Class 4 Advanced SW AN100653 16. Mira PC Patient Management SW AN100116 17. Label Printer SW AN100414 18. Power Supply Sentiero Advanced US AN101016+AN100993-USA 19. Tympanometry add-on TY-MA AN100947 20. Accessory box AB08 AN100734-P 21. Tympanometry cavity AN100549 22. Probe tip small PT-S AN100014-W (3 pcs.) 23. Probe tip medium PT-A AN100013 (5 pcs.) FDA UDI

Identifiers

Primary DI / UDI-DI: 04260223145247 FDA UDI
FDA Product Code: GWJ FDA UDI
EWO FDA UDI
ETY 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
874.1090 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 by PATH medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Evoked-potential audiometer.

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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

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Manufacturer

Manufacturer: PATH medical GmbH

Sources (1)

FDA UDI 1e17b35c-69a9-4b2d-ae09-34258877e675 33 fields · synced Jun 1, 2026