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Sign in to claim this brandWhat ELCAM MEDICAL ITALY SPA makes
ELCAM Medical Italy Spa manufactures catheter injection ports, including the model 175IBLSSC, designed for intravenous access and fluid administration in clinical settings.
The company’s catheter injection ports are classified as Class I devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database.
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 ELCAM Medical Italy Spa primarily manufacture?
ELCAM Medical Italy Spa specializes in catheter injection ports, such as the model 175IBLSSC. These devices are specifically designed for intravenous access and fluid administration in medical settings, ensuring secure and reliable connections for healthcare procedures.
Where is ELCAM Medical Italy Spa based, and what does this mean for its regulatory oversight?
ELCAM Medical Italy Spa is based in the US, which means its devices are subject to FDA regulations. The company’s products, like the catheter injection port 175IBLSSC, must comply with US regulatory requirements to be authorized for market distribution.
Which regulatory registries list ELCAM Medical Italy Spa’s devices, and why is this important?
ELCAM Medical Italy Spa’s devices, including the catheter injection port 175IBLSSC, are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, helping healthcare providers verify device authenticity and compliance with regulatory standards.
How are ELCAM Medical Italy Spa’s catheter injection ports classified under FDA regulations?
ELCAM Medical Italy Spa’s catheter injection ports, such as the 175IBLSSC, are classified as Class I devices under FDA regulations. This classification is typically assigned to low-risk devices that pose minimal potential harm to patients, often requiring less stringent premarket review compared to higher-risk categories.
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
- 513976688
Catalogue (1)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 175iblssc | 175IBLSSC | FDA UDI | Class I | Active |
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