Identity
- Trade Name
- aTymp FDA UDI
- Generic Name
- Otoacoustic emission system, battery-powered FDA UDI
- Device Name
- The aTymp system is a portable audiometric device intended for use in conduction of diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders with the help of acoustic impedance tests, including tympanometry, Eustachian tube function (for intact and perforated tympanic membrane), acoustic reflex and acoustic reflex decay. The target population for aTymp system includes all ages. During the Eustachian tube function tests patient should be able to understand and perform instructions to do maneuvers. FDA UDI
- Model / Reference
- aTymp FDA UDI
- Description
- The aTymp system is a portable audiometric device intended for use in conduction of diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders with the help of acoustic impedance tests, including tympanometry, Eustachian tube function (for intact and perforated tympanic membrane), acoustic reflex and acoustic reflex decay. The target population for aTymp system includes all ages. During the Eustachian tube function tests patient should be able to understand and perform instructions to do maneuvers. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04650075334003 FDA UDI
- FDA Product Code
- PTP FDA UDI
- GMDN Term
- Otoacoustic emission system, battery-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1090 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Otoacoustic emission system, battery-powered
aTymp by Neurosoft, Ooo — 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
- Neurosoft, Ooo
Sources (1)
- FDA UDI a4179687-db01-4bcd-b408-070923d72639 33 fields · synced Jun 6, 2026