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 and TEOAE 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. Probe EP-DP Path long AN100028-US 8. Accessory box Sentiero Combo AN100261 9. ABR Quick SW AN100337-Quick 10. TEOAE Quick SW AN100109-Quick 11. Mira PC Patient Management SW AN100116 12. Label Printer SW AN100414 13. Power Supply Sentiero Advanced US AN101016+AN100993-USA FDA UDI
Model / Reference: 100340-SC-AT FDA UDI
Description: Sentiero Advanced ABR and TEOAE 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. Probe EP-DP Path long AN100028-US 8. Accessory box Sentiero Combo AN100261 9. ABR Quick SW AN100337-Quick 10. TEOAE Quick SW AN100109-Quick 11. Mira PC Patient Management SW AN100116 12. Label Printer SW AN100414 13. Power Supply Sentiero Advanced US AN101016+AN100993-USA FDA UDI

Identifiers

Primary DI / UDI-DI: 04260223145254 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 by PATH medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Evoked-potential audiometer.

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TEOAE probe tips — Otodynamics · Class II
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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

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Manufacturer

Manufacturer: PATH medical GmbH

Sources (1)

FDA UDI 3eadbced-26f3-4a7c-9fc2-81fa3f4c25e6 33 fields · synced May 30, 2026