Identity
- Trade Name
- SERVOX digital XL FDA UDI
- Generic Name
- Transcervical artificial larynx FDA UDI
- Device Name
- The SERVOX® digital XL speech aid offers patients, who have lost their voice due to injury, illness or surgical removal of the larynx, the opportunity to quickly regain the ability to communicate. The SERVOX® digital XL can also be used by patients who are temporarily voiceless due to a tracheotomy, who have to protect their vocal folds due to illness or who are connected to a respirator. FDA UDI
- Model / Reference
- 37575 FDA UDI
- Description
- The SERVOX® digital XL speech aid offers patients, who have lost their voice due to injury, illness or surgical removal of the larynx, the opportunity to quickly regain the ability to communicate. The SERVOX® digital XL can also be used by patients who are temporarily voiceless due to a tracheotomy, who have to protect their vocal folds due to illness or who are connected to a respirator. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04040823006502 FDA UDI
- FDA Product Code
- ESE FDA UDI
- GMDN Term
- Transcervical artificial larynx FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.3375 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: Transcervical artificial larynx
SERVOX digital XL by Servona GmbH — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Servona GmbH
Sources (1)
- FDA UDI 58f97477-28df-4acb-a8a4-d696f4388b89 33 fields · synced May 30, 2026