Is this your brand? Sign in to claim ownership.
Sign in to claim this brandGRIFFIN LABORATORIES
US
Last updated May 23, 2026
What GRIFFIN LABORATORIES makes
Griffin Laboratories manufactures transcervical artificial larynx devices designed to restore speech for individuals with laryngectomy-related vocal loss. Their portfolio includes electrolarynx models that produce sound externally and transmit vibrations through the neck to the mouth, enabling communication.
These devices are classified as Class I under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States.
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 Griffin Laboratories manufacture?
Griffin Laboratories specializes in transcervical artificial larynx devices. These devices are designed to help individuals who have lost their natural voice due to laryngectomy by producing external sound that vibrates through the neck to the mouth, restoring communication. Their portfolio includes various electrolarynx models tailored for this purpose.
Where is Griffin Laboratories based?
Griffin Laboratories is headquartered in the United States. The company’s location is relevant for regulatory and operational purposes, as it influences compliance with U.S. medical device regulations and distribution networks.
Which regulatory registries list Griffin Laboratories’ devices?
Griffin Laboratories’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify device details, such as manufacturer information and classification.
How are Griffin Laboratories’ devices classified under U.S. regulations?
Griffin Laboratories’ transcervical artificial larynx devices are classified as Class I under FDA regulations. This classification is typically assigned to low-risk devices that pose minimal potential harm to patients, though compliance with manufacturing and labeling requirements remains mandatory to ensure safety and performance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 016865375
Catalogue (38)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TeliTalk™ Electrolarynx | K5200BT-FTRI | FDA UDI | Class I | Active |
| TruTone EMOTE® Electrolarynx | K1000-CAN | FDA UDI | Class I | Active |
| SolaTone® Electrolarynx | K206 | FDA UDI | Class I | Active |
| SolaTone® Electrolarynx | K280 | FDA UDI | Class I | Active |
| SolaTone Lite® Electrolarynx | K350 | FDA UDI | Class I | Active |
| SolaTone Plus™ Electrolarynx | K355 | FDA UDI | Class I | Active |
| TeliTalk™ Electrolarynx | K5200LL | FDA UDI | Class I | Active |
| TruTone® Electrolarynx | KD136 | FDA UDI | Class I | Active |
| TruTone® Electrolarynx | K136 | FDA UDI | Class I | Active |
| TruTone EMOTE® Electrolarynx | K1300 | FDA UDI | Class I | Active |
| TruTone EMOTE® Electrolarynx | K1052 | FDA UDI | Class I | Active |
| SolaTone® Electrolarynx | KD226 | FDA UDI | Class I | Active |
| TruTone® Electrolarynx | K101 | FDA UDI | Class I | Active |
| TruTone Plus® Electrolarynx | KD120 | FDA UDI | Class I | Active |
| TruTone® Electrolarynx | K150 | FDA UDI | Class I | Active |
| TruTone EMOTE® Electrolarynx | 7439 | FDA UDI | Class I | Active |
| TeliTalk™ Electrolarynx | K5200BT | FDA UDI | Class I | Active |
| SolaTone Plus™ Electrolarynx | KD355 | FDA UDI | Class I | Active |
| TruTone Plus® Electrolarynx | K120 | FDA UDI | Class I | Active |
| TruTone EMOTE® Electrolarynx | KD1000 | FDA UDI | Class I | Active |
| SolaTone Plus™ Electrolarynx | 7438 | FDA UDI | Class I | Active |
| TruTone Plus® Electrolarynx | K120 | FDA UDI | Class I | Active |
| TruTone Plus® Electrolarynx | K121 | FDA UDI | Class I | Active |
| SolaTone Plus™ Electrolarynx | K220-BRAZIL | FDA UDI | Class I | Active |
| Liberty® Electrolarynx | K306 | FDA UDI | Class I | Active |
| TeliTalk™ Electrolarynx | K5200LL-FTRI | FDA UDI | Class I | Active |
| TruTone® Electrolarynx | K152 | FDA UDI | Class I | Active |
| TruTone EMOTE® Electrolarynx | K1000 | FDA UDI | Class I | Active |
| SolaTone® Electrolarynx | K251 | FDA UDI | Class I | Active |
| SolaTone Plus™ Electrolarynx | K355-1 | FDA UDI | Class I | Active |
| SolaTone Lite® Electrolarynx | K302 | FDA UDI | Class I | Active |
| SolaTone Plus™ Electrolarynx | K355-CAN | FDA UDI | Class I | Active |
| TruTone Plus® Electrolarynx | K360-2 | FDA UDI | Class I | Active |
| TruTone Plus® Electrolarynx | KD120 | FDA UDI | Class I | Active |
| TruTone® Electrolarynx | K151 | FDA UDI | Class I | Active |
| SolaTone® Electrolarynx | K250 | FDA UDI | Class I | Active |
| SolaTone® Electrolarynx | K276 | FDA UDI | Class I | Active |
| TruTone Plus® Electrolarynx | 7444 | FDA UDI | Class I | Unknown |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.