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Sign in to claim this brandFerrosan Meidcal Devices A/S
US
Last updated May 23, 2026
What Ferrosan Meidcal Devices A/S makes
Ferrosan Medical Devices A/S manufactures absorbable gelatin sponges, designed for surgical use to control bleeding and promote hemostasis during procedures. These products are intended for temporary use, as they are absorbed by the body over time.
The company’s portfolio is regulated under FDA’s Class III designation, requiring Premarket Approval (PMA) for these devices. The products are listed with the FDA under the PMA regulatory pathway, and the manufacturer operates from 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 does Ferrosan Medical Devices A/S manufacture?
Ferrosan Medical Devices A/S manufactures absorbable gelatin sponges, specifically the SURGIFOAM® Absorbable Gelatin Sponge, which are designed for surgical use to control bleeding and promote hemostasis during procedures.
Where is Ferrosan Medical Devices A/S based?
Ferrosan Medical Devices A/S operates from the United States, as indicated in the provided device data.
Which regulatory registries list Ferrosan Medical Devices A/S products?
Ferrosan Medical Devices A/S products are listed in the FDA's PMA (Premarket Approval) registry, as their devices are classified under FDA's Class III designation requiring PMA.
How are Ferrosan Medical Devices A/S products classified?
Ferrosan Medical Devices A/S products are classified under FDA's Class III designation, which is the highest risk category requiring Premarket Approval (PMA) for marketing authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SURGIFOAM® Absorbable Gelatin Powder Kit | 1979 | FDA UDI | Class III | Active |
| SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. | 1973 | FDA UDI | Class III | Active |
| SURGIFLO® Hemostatic Matrix Kit with Thrombin | 2994 | FDA UDI | Class III | Active |
| SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Hemorrhoidectomy Sponge | 1977 | FDA UDI | Class III | Active |
| SURGIFOAM® Absorbable Gelatin Powder | 1978 | FDA UDI | Class III | Active |
| SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. | 1975 | FDA UDI | Class III | Active |
| SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. | 1972 | FDA UDI | Class III | Active |
| SURGIFLO® Hemostatic Matrix | 2991 | FDA UDI | Class III | Active |
| SURGIFLO® Hemostatic Matrix Kit with Thrombin | 2993 | FDA UDI | Class III | Unknown |
| SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. | 1974 | FDA UDI | Class III | Active |
| SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Oral Sponge | 1969 | FDA UDI | Class III | Active |
| SURGIFOAM® Absorbable Gelatin Sponge | P990004 | FDA PMA | Class III | Active |
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