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 Easy Diag 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. PATH Insert Earphones (PIEP) AN100860 8. ABR Quick SW AN100337 9. Binaural ABR SW AN100424 10. ABR FFC/FS SW AN100466 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-ED FDA UDI
Description: Sentiero Advanced Easy Diag 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. PATH Insert Earphones (PIEP) AN100860 8. ABR Quick SW AN100337 9. Binaural ABR SW AN100424 10. ABR FFC/FS SW AN100466 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: 04260223145209 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

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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 a42eb526-2563-43ad-85ea-64a1f313b5a2 33 fields · synced May 30, 2026