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Sign in to claim this brandSilverStream Medical Ltd.
US
Last updated May 30, 2026
What SilverStream Medical Ltd. makes
SilverStream Medical Ltd. produces antimicrobial wound irrigation solutions designed to reduce bacterial load in acute and chronic wounds during irrigation procedures. The product is formulated to be used in clinical and over-the-counter settings for wound care applications.
The company’s portfolio is classified under FDA’s Class II device category and is listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer 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 SilverStream Medical Ltd. manufacture?
SilverStream Medical Ltd. specializes in antimicrobial wound irrigation solutions. These products are formulated to help reduce bacterial load in wounds during irrigation, making them suitable for both clinical and over-the-counter use in wound care applications.
Where is SilverStream Medical Ltd. based, and how does that affect its regulatory standing?
SilverStream Medical Ltd. is based in the United States. Since the company’s devices are regulated by the FDA, they must comply with U.S. medical device regulations, including classification under the FDA’s device classification system and potential UDI listing requirements.
How are SilverStream Medical Ltd.’s devices classified by the FDA, and why does this matter?
SilverStream Medical Ltd.’s devices fall under the FDA’s Class II category. This classification means they are considered moderate-risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance, rather than pre-market approval.
Are SilverStream Medical Ltd.’s devices listed in any regulatory registries, and what does that mean?
Yes, SilverStream Medical Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This listing helps ensure traceability, transparency, and proper identification of the devices in clinical and commercial settings, supporting regulatory compliance and patient safety.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- silverstreammed.com
- —
- —
- [email protected]
- Phone
- +14708633009
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 533346805
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Silverstream | SS-1000-02 | FDA UDI | U | Active |
| Silverstream | SS-1000-01 | FDA UDI | U | Active |
| Silverstream OTC | SS-1000-01 | FDA UDI | U | Active |
| Silverstream OTC | SS-1000-03 | FDA UDI | U | Active |
| Silverstream | SS-1000-03 | FDA UDI | U | Active |
| Silverstream OTC | SS-1000-02 | FDA UDI | U | Active |
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