Identity
- Trade Name
- Live speech microphone MIC-01 EUDAMEDLive Speech Microphone FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Live Speech Microphone EUDAMED
- Model / Reference
- 100779 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223141720 EUDAMEDFDA UDI
- Basic UDI-DI
- 0426022Sentiero-199 EUDAMED
- 510(k) Number
- K133012 FDA UDI
- FDA Product Code
- EWO FDA UDIGWJ FDA UDI
- EMDN Code
- Z121401 AUDIOMETERS EUDAMED
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1050 FDA UDI882.1900 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
No
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
Live Speech Microphone by PATH medical GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0426022Sentiero-199 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- PATH MEDICAL GmbH
- EUDAMED SRN
- DE-MF-000006935
Sources (3)
- EUDAMED 266ecad9-e102-42c5-a733-546f2c56ff34 61 fields · synced Jun 18, 2026
- FDA UDI fa91c329-8089-4290-9848-0bd30ed21a20 33 fields · synced May 29, 2026
- EUDAMED e0b53fff-9520-429e-a430-81b4579aac03 61 fields · synced Jun 18, 2026