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Sign in to claim this brandRALCO SRL
US
Last updated May 25, 2026
What RALCO SRL makes
Ralco SRL manufactures diagnostic x-ray system collimators, including models with automatic aperture control and both motorized and non-motorized manual aperture adjustments. These devices are designed to regulate and limit the x-ray beam size during imaging procedures, ensuring precise exposure settings for medical diagnostics.
The company’s products fall under Class II regulatory classification in the US, with devices listed in the FDA’s Unique Device Identifier (UDI) database. Ralco SRL 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 Ralco SRL manufacture?
Ralco SRL specializes in diagnostic x-ray system collimators. These devices control and limit the size of the x-ray beam during imaging, ensuring accurate and safe exposure settings. Their product line includes collimators with automatic aperture control, as well as manual-aperture models that are either motorized or non-motorized.
Where is Ralco SRL based?
Ralco SRL is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance processes, particularly for devices marketed in the US.
How are Ralco SRL’s devices classified in the US?
Ralco SRL’s diagnostic x-ray system collimators fall under Class II regulatory classification in the US. This classification is assigned based on risk assessment—Class II devices generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.
Are Ralco SRL’s devices listed in any regulatory registries?
Yes, Ralco SRL’s devices are included in the FDA’s Unique Device Identifier (UDI) database. Listing in the UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability for regulatory and market surveillance purposes.
Why does the regulatory classification matter for Ralco SRL’s collimators?
The Class II classification for Ralco SRL’s collimators means these devices undergo additional scrutiny beyond basic safety requirements. This includes compliance with special controls—specific regulations, guidelines, or other measures—designed to mitigate risks associated with x-ray exposure precision and patient safety. The classification ensures that devices meet performance standards while balancing innovation with regulatory oversight.
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
- 428769327
Catalogue (22)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ralco srl | P 313/A DHHS | FDA UDI | Class II | Active |
| Ralco srl | R 302 ACS/A DHHS | FDA UDI | Class II | Active |
| Ralco srl | R 225 DHHS | FDA UDI | Class II | Active |
| Ralco srl | R 108 DHHS | FDA UDI | Class II | Active |
| Ralco srl | R 302 DMLP DHHS | FDA UDI | Class II | Active |
| Ralco srl | P 225 ACS DHHS | FDA UDI | Class II | Active |
| Ralco srl | R 302/144/A DHHS | FDA UDI | Class II | Active |
| Ralco srl | R 108 F DHHS | FDA UDI | Class II | Active |
| Ralco srl | R 605 DASM DHHS | FDA UDI | Class II | Active |
| Ralco srl | R 221/A DHHS | FDA UDI | Class II | Active |
| Ralco srl | R 302 MLPI/A DHHS | FDA UDI | Class II | Active |
| Ralco srl | R 302 MLP/A DHHS | FDA UDI | Class II | Active |
| Ralco srl | R 915 S DHHS | FDA UDI | Class II | Active |
| Ralco srl | P 232 DHHS | FDA UDI | Class II | Active |
| Ralco srl | R 302/A DHHS | FDA UDI | Class II | Active |
| Ralco srl | R 221 ACS DHHS | FDA UDI | Class II | Active |
| Ralco srl | S 605 DASM DHHS | FDA UDI | Class II | Active |
| Ralco srl | R 302 DACS/A DHHS | FDA UDI | Class II | Active |
| Ralco srl | R 302 L/A DHHS | FDA UDI | Class II | Active |
| Ralco srl | R 72 DHHS | FDA UDI | Class II | Active |
| Ralco srl | R 72 S DHHS | FDA UDI | Class II | Active |
| Ralco srl | R 225 ACS DHHS | FDA UDI | Class II | Active |
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