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Sign in to claim this brandSofregen Medical, Inc.
US
Last updated May 30, 2026
What Sofregen Medical, Inc. makes
Sofregen Medical, Inc. produces synthetic injectable implants for vocal cord medialization, including the SilkVoice and SERI Contour devices. These products are designed to restore voice quality by repositioning or augmenting the vocal cords. The portfolio also includes variations of the SilkVoice implant, tailored for different clinical applications.
The company’s devices are classified as Class II under US regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The portfolio is authorised for commercial distribution in the United States, where the manufacturer is based.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Sofregen Medical, Inc. manufacture?
Sofregen Medical, Inc. specializes in synthetic injectable implants used for vocal cord medialization. These devices, such as the SilkVoice and SERI Contour, are designed to improve voice quality by repositioning or augmenting the vocal cords. The implants are tailored for specific clinical needs, including variations of the SilkVoice implant.
Where is Sofregen Medical, Inc. based, and where are its devices authorised for use?
Sofregen Medical, Inc. is based in the United States. Its devices, including the SilkVoice and SERI Contour implants, are authorised for commercial distribution in the US market. The company’s focus is on vocal cord medialization solutions, which are regulated under US medical device laws.
Which regulatory registries list Sofregen Medical, Inc.’s devices?
Sofregen Medical, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These registries track medical devices that have undergone the necessary regulatory pathways to be authorised for distribution in the US.
How are Sofregen Medical, Inc.’s devices classified under US regulations?
Sofregen Medical, Inc.’s devices, such as the SilkVoice and SERI Contour implants, fall under Class II classification in the US regulatory system. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as pre-market notifications (510(k)) before commercial distribution.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- sofregen.com
- —
- —
- [email protected]
- Phone
- 6176518873
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 079710838
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Seri | 94680 | FDA UDI | Class II | Unknown |
| Seri | 94679 | FDA UDI | Class II | Unknown |
| Seri | 94678 | FDA UDI | Class II | Unknown |
| SilkVoice | SV3001 | FDA UDI | Class II | Active |
| SilkVoice | SV1001 | FDA UDI | Class II | Active |
| SERI Contour | 95512 | FDA UDI | Class II | Unknown |
| SilkVoice | SV2001 | FDA UDI | Class II | Active |
| Seri | 94677 | FDA UDI | Class II | Unknown |
| SilkVoice | SV1001 | FDA UDI | Class II | Active |
| SilkVoice | SV1002 | FDA UDI | Class II | Active |
| SilkVoice | SV3001 | FDA UDI | Class II | Active |
| SilkVoice | SV2001 | FDA UDI | Class II | Active |
| SilkVoice | SV1002 | FDA UDI | Class II | Active |
| Silk Voice (SMI-04) | K240919 | FDA 510(k) | Class II | Active |
| Silk Voice | K180631 | FDA 510(k) | Class II | Active |
| SERI Contour | K172545 | FDA 510(k) | Class II | Active |
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