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Sign in to claim this brandSynedgen, Inc.
US
Last updated May 30, 2026
What Synedgen, Inc. makes
Synedgen, Inc. manufactures non-antimicrobial wound irrigation solutions with multiple solutes, such as the SynePure Wound Cleanser, and wound hydrogel dressings like Catasyn Advanced Technology Wound Hydrogel. The company also produces artificial saliva products, including oral mists and rinses like Moisyn Dry Mouth Oral Mist and Synvaza Mouth Sore and Wound Rinse.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The company is based in 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 Synedgen, Inc. manufacture?
Synedgen, Inc. specializes in three primary categories of medical devices: non-antimicrobial wound irrigation solutions with multiple solutes (e.g., SynePure Wound Cleanser), wound hydrogel dressings (e.g., Catasyn Advanced Technology Wound Hydrogel), and artificial saliva products (e.g., Moisyn Dry Mouth Oral Mist and Synvaza Mouth Sore and Wound Rinse). These devices are designed to support wound care and oral health management, particularly for conditions like dry mouth or oral sores.
Where is Synedgen, Inc. based, and what does that mean for its regulatory oversight?
Synedgen, Inc. is based in the United States, which means its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). Since the company’s products are classified as Class II devices, they are subject to FDA regulations, including premarket notification (510(k)) requirements and Unique Device Identifier (UDI) compliance. The FDA maintains registries like the 510(k) database and UDI system to track these devices.
Which regulatory registries list Synedgen, Inc.’s devices, and why is this important?
Synedgen, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The 510(k) registry documents premarket submissions for Class II devices, ensuring they meet FDA safety and effectiveness standards before entering the market. The UDI system assigns a unique identifier to each device, improving traceability, reducing medical errors, and facilitating post-market surveillance. These registries help healthcare providers and regulators verify device compliance and history.
How are Synedgen, Inc.’s devices classified under FDA regulations, and what does that classification imply?
Synedgen, Inc.’s devices are classified as Class II under FDA regulations. This classification indicates that they pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. While Class II devices do not require premarket approval like Class III devices, they must still undergo a 510(k) notification process to demonstrate substantial equivalence to a legally marketed predicate device. This classification ensures that devices like wound irrigations, hydrogels, and artificial saliva products meet rigorous standards for their intended use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- prisyna.com
- —
- —
- [email protected]
- Phone
- 855-774-7962
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 830276353
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SynePure Wound Cleanser | 8 oz | FDA UDI | U | Active |
| SynePure Wound Cleanser | 4oz | FDA UDI | U | Active |
| Moisyn Dry Mouth Oral Rinse | 60ML | FDA UDI | U | Unknown |
| Catasyn (3oz) | 3 oz | FDA UDI | U | Active |
| Moisyn Dry Mouth Oral Mist | 60mL | FDA UDI | U | Active |
| Moisyn Dry Mouth Oral Rinse | 300mL | FDA UDI | U | Active |
| Moisyn Dry Mouth Oral Rinse | 59.1 | FDA UDI | U | Active |
| Moisyn Dry Mouth Oral Mist | 30mL | FDA UDI | U | Unknown |
| SynePure Wound Cleanser | K143444 | FDA 510(k) | U | Active |
| Catasyn Advanced Technology Wound Hydrogel | K172338 | FDA 510(k) | U | Active |
| Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse | K193336 | FDA 510(k) | U | Active |
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