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NavPro ONE Device with touchscreen
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 100360-NPOModel SOH100098
Identity
- Trade Name
- NavPRO ONE EUDAMEDNavPro ONE Device with touchscreen FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Sentiero EUDAMEDNavPRO One branded Sentiero Advanced FDA UDI
- Model / Reference
- 100360-NPO EUDAMEDFDA UDISOH100098 EUDAMED
- Description
- NavPRO One branded Sentiero Advanced FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223143311 EUDAMEDFDA UDI
- Basic UDI-DI
- 0426022Sentiero-2aHJ EUDAMED
- FDA Product Code
- GWJ FDA UDIEWO FDA UDIETY FDA UDI
- EMDN Code
- Z121401,Z12140302,Z12149001,Z12149005 EUDAMED
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1900 FDA UDI874.1050 FDA UDI874.1090 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Evoked-potential audiometer
NavPro ONE Device with touchscreen by PATH medical GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Evoked-potential audiometer.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- PATH medical GmbH
Sources (2)
- FDA UDI 8f26c093-8e01-4b5d-968c-46fa799e0bc1 33 fields · synced Jul 8, 2026
- EUDAMED 38f4c2e7-6327-4ef8-b4ea-0407577108c0 61 fields · synced Jul 8, 2026