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Sign in to claim this brandIMBED BIOSCIENCES, INC.
US
Last updated September 17, 2026
What IMBED BIOSCIENCES, INC. makes
IMBed Biosciences, Inc. manufactures hydrophilic-gel and antimicrobial exudate-absorbent first aid dressings designed for wound care. Products include antimicrobial-coated and pain-relieving variants, as well as veterinary-specific formulations.
These devices are classified as Class II under FDA regulations and are authorised via 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. 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 IMBed Biosciences, Inc. manufacture?
IMBed Biosciences, Inc. specializes in exudate-absorbent first aid dressings. Their products are primarily hydrophilic-gel dressings, some of which incorporate antimicrobial properties to help manage wound care. Examples include dressings like Surgaflex, PelashieldAM, and Microlyte Matrix, with variations designed for pain relief or veterinary use.
Where is IMBed Biosciences, Inc. based?
IMBed Biosciences, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance, as its devices are authorised under U.S. regulatory frameworks.
How are IMBed Biosciences, Inc.’s devices classified under FDA regulations?
IMBed Biosciences, Inc.’s exudate-absorbent dressings fall under Class II classification in the FDA’s regulatory system. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as premarket notifications.
Which regulatory registries or databases list IMBed Biosciences, Inc.’s devices?
IMBed Biosciences, Inc.’s devices are authorised through the FDA’s 510(k) premarket notification process and are also tracked via the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with U.S. medical device regulations.
Why do IMBed Biosciences, Inc.’s dressings require premarket notification (510(k))?
The FDA’s 510(k) premarket notification is required for Class II devices like IMBed’s exudate-absorbent dressings because they are not considered low-risk (Class I) but also do not pose high risk (Class III). The process ensures that these devices meet specific performance standards and safety requirements before entering the market.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 2241 Pinehurst Dr, Middleton, WI, 53562
- Website
- imbedbio.com
- —
- —
- [email protected]
- Phone
- 888-472-9898
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3013478891
- DUNS Number
- 962084500
Catalogue (45)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Surgaflex | 91017 | FDA UDI | U | Active |
| PelashieldAM | PS1023 | FDA UDI | U | Active |
| Microlyte Matrix | ML16DISC | FDA UDI | U | Active |
| Microlyte Matrix | ML0303 | FDA UDI | U | Active |
| Microlyte Ag VET | 99000 | FDA UDI | U | Active |
| Surgaflex PainGuard | SFPG0406 | FDA UDI | U | Active |
| Microlyte PainGuard | MLPG1010 | FDA UDI | U | Active |
| Microlyte Matrix | ML0404 | FDA UDI | U | Active |
| Microlyte Matrix | ML1023 | FDA UDI | U | Active |
| PelashieldAM | PS0523 | FDA UDI | U | Active |
| Surgaflex PainGuard | SFPG0203 | FDA UDI | U | Active |
| Surgaflex | SF0406 | FDA UDI | U | Active |
| Surgaflex | 91018 | FDA UDI | U | Active |
| Microlyte Matrix | 91007 | FDA UDI | U | Active |
| Microlyte Ag VET | 99001 | FDA UDI | U | Active |
| PelashieldAM | PS1515 | FDA UDI | U | Active |
| Surgaflex | 91017 | FDA UDI | U | Active |
| Pelashield PainGuard | PSPG1515 | FDA UDI | U | Active |
| Surgaflex PainGuard | SFPG0420 | FDA UDI | U | Active |
| Microlyte AG | 91001 | FDA UDI | U | Unknown |
| Surgaflex PainGuard | SFPG0410 | FDA UDI | U | Active |
| Microlyte Matrix | 91006 | FDA UDI | U | Active |
| Microlyte Matrix | ML0202 | FDA UDI | U | Active |
| Microlyte Matrix | 91006 | FDA UDI | U | Active |
| Microlyte Matrix | 91001 | FDA UDI | U | Active |
| Microlyte Ag-Lidocaine Matrix | 91010 | FDA UDI | U | Active |
| Microlyte Matrix | ML0523 | FDA UDI | U | Active |
| Microlyte PainGuard | MLPG0505 | FDA UDI | U | Active |
| Surgaflex | 91018 | FDA UDI | U | Active |
| MicroLyte Ag | 91002 | FDA UDI | U | Unknown |
| Microlyte Matrix | 91002 | FDA UDI | U | Active |
| Microlyte PainGuard | MLPG0303 | FDA UDI | U | Active |
| Microlyte Matrix | ML0505 | FDA UDI | U | Active |
| Microlyte Ag-Lidocaine Matrix | 91011 | FDA UDI | U | Active |
| Surgaflex | SF0203 | FDA UDI | U | Active |
| Microlyte Matrix | ML1515 | FDA UDI | U | Active |
| Microlyte Matrix | 91007 | FDA UDI | U | Active |
| Microlyte Matrix | 91008 | FDA UDI | U | Active |
| Microlyte Matrix | ML1010 | FDA UDI | U | Active |
| Microlyte Ag-Lidocaine Matrix | 91009 | FDA UDI | U | Active |
| Microlyte Matrix | 91008 | FDA UDI | U | Active |
| Surgaflex | SF0420 | FDA UDI | U | Active |
| Pelashield PainGuard | PSPG1023 | FDA UDI | U | Active |
| Microlyte Ag/Lidocaine | K211943 | FDA 510(k) | U | Active |
| Microlyte Ag | K153756 | FDA 510(k) | U | Active |
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