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Sign in to claim this brandNitiloop , Ltd.
US
Last updated May 25, 2026
What Nitiloop , Ltd. makes
Nitiloop, Ltd. manufactures vascular microcatheters, including the NovaCross, NovaCross Microcatheter, and NovaCross CTO Microcatheter.
The company's devices are classified as Class II and are listed in the FDA 510(k) and FDA UDI registries. Nitiloop, Ltd. is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Nitiloop, Ltd. manufacture?
Nitiloop, Ltd. manufactures vascular microcatheters, including the NovaCross, NovaCross Microcatheter, and NovaCross CTO Microcatheter. These devices are designed for use in vascular procedures.
Where is Nitiloop, Ltd. based?
Nitiloop, Ltd. is based in the United States. The company operates from its headquarters located in the US, where it develops and manufactures its vascular microcatheter products.
Which regulatory registries list Nitiloop's devices?
Nitiloop's devices are listed in the FDA 510(k) and FDA UDI registries. These listings indicate that the company's products are registered with the US Food and Drug Administration for regulatory purposes.
How are Nitiloop's devices classified?
Nitiloop's devices are classified as Class II medical devices. This classification indicates moderate-risk devices that require special controls to ensure their safety and effectiveness in clinical use.
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
- 649175353
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NovaCross | Xtreme | FDA UDI | Class II | Active |
| NovaCross Microcatheter | 001 | FDA UDI | Class II | Active |
| NovaCross Microcatheter | K143608 | FDA 510(k) | Class II | Active |
| NovaCross Microcatheter | K172297 | FDA 510(k) | Class II | Active |
| NovaCross CTO Microcatheter | K193322 | FDA 510(k) | Class II | Active |
| NovaCross Microcatheter | K160389 | FDA 510(k) | Class II | Active |
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