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Sign in to claim this brandPlan 1 Health, S.R.L.
US
Last updated May 31, 2026
What Plan 1 Health, S.R.L. makes
Plan 1 Health, S.R.L. manufactures anaesthesia conduction catheterization kits, specifically the PAINfusor Catheter, designed for targeted drug delivery in medical procedures requiring precise catheter placement.
The company’s products are classified as Class II devices and are listed under FDA 510(k) and UDI registries. 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 Plan 1 Health, S.R.L. manufacture?
Plan 1 Health, S.R.L. specializes in anaesthesia conduction catheterization kits, specifically the PAINfusor Catheter. These devices are engineered for targeted drug delivery during medical procedures where accurate catheter placement is critical, such as pain management or regional anaesthesia.
Where is Plan 1 Health, S.R.L. based?
Plan 1 Health, S.R.L. is headquartered in the United States. The company’s location is relevant for regulatory compliance and reporting purposes, particularly when navigating U.S. device authorization pathways.
Which regulatory registries list Plan 1 Health, S.R.L.’s devices?
Plan 1 Health, S.R.L.’s devices are listed under the FDA’s 510(k) premarket notification process and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with U.S. medical device regulations.
How are Plan 1 Health, S.R.L.’s devices classified under U.S. regulations?
Plan 1 Health, S.R.L.’s devices, including the PAINfusor Catheter, fall under Class II classification in the U.S. This classification is assigned based on the risk level of the device, requiring special controls beyond general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- p1h.it
- —
- —
- [email protected]
- Phone
- +390433468376
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 541972329
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PAINfusor Catheter | 2.5 cm - 1" | FDA UDI | Class II | Active |
| PAINfusor Catheter | 7.5 cm - 3" | FDA UDI | Class II | Active |
| PAINfusor Catheter | 30 cm - 12" | FDA UDI | Class II | Active |
| PAINfusor Catheter | 22.5 cm - 9" | FDA UDI | Class II | Active |
| PAINfusor Catheter | 15 cm - 6" | FDA UDI | Class II | Active |
| Painfusor Catheter | K111031 | FDA 510(k) | Class II | Active |
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