Identity
- Trade Name
- Audioscan Probe Tube FDA UDI
- Generic Name
- Audiometric/hearing aid tester FDA UDI
- Device Name
- Molded probe tube, consisting of a thin silicone tube, molded collar, and adjustable ring marker. FDA UDI
- Model / Reference
- RE367 FDA UDI
- Description
- Molded probe tube, consisting of a thin silicone tube, molded collar, and adjustable ring marker. FDA UDI
Identifiers
- Catalog Number
- RE367-40 FDA UDI
- Primary DI / UDI-DI
- B161RE3670 FDA UDI
- FDA Product Code
- ETW FDA UDI
- GMDN Term
- Audiometric/hearing aid tester FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Audiometric/hearing aid tester
Audioscan Probe Tube by Etymonic Design Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Audiometric/hearing aid tester.
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- REAL-EAR — WS Audiology USA, Inc. · Class II
- REAL-EAR — WS Audiology USA, Inc. · Class II
- Unity 4 / Measure — Auditdata A/S · Class II
- Unity 4 — Auditdata A/S · Class II
- REAL-EAR — WS Audiology USA, Inc. · Class II
- Etymotic Research — ETYMOTIC RESEARCH, INC. · Class II
- Sanibel Supply A/S — Interacoustics A/S · 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
- Etymonic Design Incorporated
Sources (1)
- FDA UDI e48fb040-ef48-462b-bc62-77eca8b4b054 35 fields · synced Jun 1, 2026