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Sign in to claim this brandEssebi Medical Srl
US
Last updated May 30, 2026
What Essebi Medical Srl makes
Essebi Medical Srl produces patient positioning foam mould kits designed to immobilize and support patients during medical procedures. Their primary product, the TOTIM Patient Cushion Immobilization System, is tailored for use in clinical settings to enhance stability and comfort for patients undergoing imaging or treatment.
The company’s devices fall under FDA Class II regulation and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. 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 Essebi Medical Srl manufacture?
Essebi Medical Srl specializes in patient positioning foam mould kits, specifically the TOTIM Patient Cushion Immobilization System. These devices are designed to immobilize and support patients during medical procedures, ensuring stability and comfort during imaging or treatment.
Where is Essebi Medical Srl based?
Essebi Medical Srl is headquartered in the United States. The company’s location influences its regulatory compliance and reporting requirements, particularly for devices authorized in the U.S. market.
Which regulatory registries list Essebi Medical Srl’s devices?
Essebi Medical Srl’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries help track and identify medical devices authorized for commercial distribution in the U.S.
How are Essebi Medical Srl’s devices classified under FDA regulations?
Essebi Medical Srl’s devices fall under FDA Class II classification. This classification applies to devices that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as patient positioning foam mould kits.
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
- 440317440
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TOTIM Patient Cushion Immobilization System | TTM3002 JOLLY | FDA UDI | Class II | Active |
| TOTIM Patient Cushion Immobilization System | TTM3009 TOTAL BODY | FDA UDI | Class II | Active |
| TOTIM Patient Cushion Immobilization System | TTM3002L JOLLY L | FDA UDI | Class II | Active |
| TOTIM Patient Cushion Immobilization System | TTM3005M CERVICAL M | FDA UDI | Class II | Active |
| TOTIM Patient Cushion Immobilization System | TTM3001L BODY L | FDA UDI | Class II | Active |
| TOTIM Patient Cushion Immobilization System | TTM3010M NECK M | FDA UDI | Class II | Active |
| TOTIM Patient Cushion Immobilization System | K190894 | FDA 510(k) | Class II | Active |
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