Identity
- Trade Name
- Maico FDA UDI
- Generic Name
- Tone audiometer FDA UDI
- Model / Reference
- Pilot Test FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260176126935 FDA UDI
- FDA Product Code
- EWO FDA UDI
- GMDN Term
- Tone audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 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: Tone audiometer
Maico by MAICO Diagnostics GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tone audiometer.
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- VIOLA — INVENTIS SRL · Class II
- VIOLA — INVENTIS SRL · Class II
- nanoAudio DD45 Set with Patient Response Button — PATH medical GmbH · Class II
- GN Otometrics A/S — Natus Medical Denmark ApS · 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
- MAICO Diagnostics GmbH
Sources (1)
- FDA UDI 581b59f0-2f08-4119-8c68-f664ce654ff3 32 fields · synced Jun 8, 2026