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US
Last updated May 23, 2026
What Polynovo Biomaterials Pty, Ltd. makes
Polynovo Biomaterials Pty, Ltd. manufactures synthetic wound matrix dressings designed to support tissue regeneration and wound healing. Their portfolio includes products like NovoSorb SynPath, NovoSorb BTM, and NovoSorb MTX, which are intended for use in acute and chronic wound care applications.
The company’s devices are classified as Class II and Unclassified (U) under FDA regulations and are listed via 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. 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 Polynovo Biomaterials Pty, Ltd. primarily manufacture?
Polynovo Biomaterials Pty, Ltd. specializes in synthetic wound matrix dressings. These products are designed to aid tissue regeneration and wound healing, particularly for acute and chronic wounds. The focus is on creating materials that promote a supportive environment for healing without relying on biological tissues.
Where is Polynovo Biomaterials Pty, Ltd. based, and how does that affect its regulatory oversight?
The company is based in the United States, which means its devices fall under FDA jurisdiction. Since the devices are classified as Class II or Unclassified (U), they require regulatory pathways like 510(k) premarket notifications or UDI listing to demonstrate compliance with FDA standards before commercial distribution.
Which regulatory registries or databases list Polynovo Biomaterials Pty, Ltd.’s devices?
Polynovo Biomaterials Pty, Ltd.’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance tracking for Class II and Unclassified devices, helping healthcare providers and regulators verify product details and approval status.
How are Polynovo Biomaterials Pty, Ltd.’s devices classified under FDA regulations, and why does this matter?
The company’s devices are classified as Class II or Unclassified (U) under FDA regulations. Class II devices require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance, while Unclassified devices may undergo 510(k) clearance or other pathways to demonstrate compliance. This classification influences the regulatory pathway and oversight required before the devices can be legally marketed.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (19)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NovoSorb SynPath | SYN-0304 | FDA UDI | U | Active |
| NovoSorb BTM | BTM-1020 | FDA UDI | U | Active |
| NovoSorb BTM | BTM-0505 | FDA UDI | U | Active |
| NovoSorb MTX | MTX-0505 | FDA UDI | U | Active |
| NovoSorb BTM | BTM-2040 | FDA UDI | U | Active |
| NovoSorb BTM | BTM-1010 | FDA UDI | U | Active |
| NovoSorb MTX | MTX-2040 | FDA UDI | U | Active |
| NovoSorb SynPath | SYN-0505 | FDA UDI | U | Active |
| NovoSorb MTX | MTX-1020 | FDA UDI | U | Active |
| NovoSorb SynPath | SYN-0202 | FDA UDI | U | Active |
| NovoSorb SynPath | SYN-1010 | FDA UDI | U | Active |
| NovoSorb MTX | MTX-1010 | FDA UDI | U | Active |
| NovoSorb SynPath | SYN-0203 | FDA UDI | U | Active |
| Novopore Dressing | K132936 | FDA 510(k) | Class II | Active |
| NovoSorb BTM | K251567 | FDA 510(k) | U | Active |
| BTM Wound Dressing | K142879 | FDA 510(k) | U | Active |
| NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) | K172140 | FDA 510(k) | U | Active |
| NovoSorb Matrix | K221686 | FDA 510(k) | U | Active |
| NovoSorb® MTX | K242149 | FDA 510(k) | U | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Polynovo Biomaterials Pty Ltd Port Melbourne Victoria · AU FEI 3007886187