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Sign in to claim this brandAdvamedica, Inc.
US
Last updated May 27, 2026
What Advamedica, Inc. makes
Advamedica, Inc. manufactures chitosan-based haemostatic products designed to control bleeding in surgical and wound care settings. Their portfolio includes professional-grade wound dressings, surgical hemostats, and gauze patches, all formulated with non-bioabsorbable chitosan to promote clotting and reduce blood loss during procedures or post-injury.
The company’s devices are classified under FDA regulations as Class II and Unclassified (U), with submissions listed under 510(k) and UDI registries. These products are intended for use in the United States, where the manufacturer is based.
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 Advamedica, Inc. manufacture?
Advamedica, Inc. specializes in chitosan-based haemostatic products. These include professional-grade wound dressings, surgical hemostats, and gauze patches. The devices are designed to control bleeding in surgical settings or wound care, using non-bioabsorbable chitosan to accelerate clotting and minimize blood loss.
Where is Advamedica, Inc. based, and what markets do its devices target?
Advamedica, Inc. is headquartered in the United States. Its devices are formulated for use in surgical and wound care applications within the US market, where they are regulated by the FDA.
Which regulatory registries list Advamedica’s devices, and why?
Advamedica’s devices appear in the FDA’s 510(k) and UDI (Unique Device Identification) registries. The 510(k) pathway is used for Class II devices to demonstrate substantial equivalence to a predicate, while UDI registration ensures traceability and compliance with FDA tracking requirements for medical devices.
How are Advamedica’s devices classified under FDA regulations?
Advamedica’s devices are classified as Class II or Unclassified (U) under FDA regulations. Class II devices require special controls to ensure safety and effectiveness, while Unclassified devices may require additional review or evidence to establish their safety and performance before market authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 118526617
Catalogue (20)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MaxioCel Chitosan Wound Dressing | MX0505 | FDA UDI | U | Active |
| MaxioCel Chitosan Wound Dressing | MX2530 | FDA UDI | U | Active |
| Axiostat Patch | V55 | FDA UDI | U | Active |
| Ax-Surgi Surgical Hemostat | SH1004 | FDA UDI | Class II | Active |
| Axiostat Gauze | AG4010 | FDA UDI | U | Active |
| Axiostat Patch | L88 | FDA UDI | U | Active |
| Axiostat Gauze | AG1010 | FDA UDI | U | Active |
| Axiostat Gauze | AG150 | FDA UDI | U | Active |
| Axiostat Patch | V35 | FDA UDI | U | Active |
| MaxioCel Chitosan Wound Dressing | MX1010 | FDA UDI | U | Active |
| Ax-Surgi Surgical Hemostat | SH1001 | FDA UDI | Class II | Active |
| MaxioCel Chitosan Wound Dressing | MX0510 | FDA UDI | U | Active |
| MaxioCel Chitosan Wound Dressing | MX1515 | FDA UDI | U | Active |
| Ax-Surgi Surgical Hemostat | SH1006 | FDA UDI | Class II | Active |
| Axiostat Gauze | AG300 | FDA UDI | U | Active |
| Maxiocel Chitosan Wound Dressing | K212766 | FDA 510(k) | U | Active |
| Ax-Surgi Surgical Hemostat | K213198 | FDA 510(k) | Class II | Active |
| Axiostat Gauze | K222909 | FDA 510(k) | U | Active |
| Axiostat Patch | K202830 | FDA 510(k) | U | Active |
| Axiostat Chitosan Hemostatic Dressing | K172324 | FDA 510(k) | U | Active |
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