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Sign in to claim this brandPLAN 1 HEALTH S.r.l.
Italy·IT-MF-000022746
Last updated June 8, 2026
About
All medical devices placed on the market are subject to strict controls prior to CE marking, which means that all the requirements laid down by standards, for example, safety, choice of materials, biocompatibility, are satisfied. From early 2024 Plan1Health completed the migration of all its devices under the new MDR regulation with the notified TUV South. Today Plan 1 Health is part of the POLYMED Group, which is also a distributor – importer for Italy and Switzerland.
Translated from the manufacturer's own website. Source
Information
- Country
- Italy
- Address
- 5, VIA FRATELLI SOLARI, AMARO (UD), Italy
- Website
- www.p1h.it
- —
- [email protected]
- Phone
- +390433468376
- PRRC Contact
- LUCA GIORGINI
- EUDAMED SRN
- IT-MF-000022746
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (58)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PAINfusor Catheter 15cm | 203.06.10.15T | EUDAMED | Class IIa | Active |
| PEEL-AWAY Introducer 4FR x 5cm | 201.60.63.40 | EUDAMED | Class IIa | Active |
| Straight Nitinol Mandrel Length 800mm Ø0, 445mm | 201.60.60.14 | EUDAMED | Class IIa | Active |
| PEEL-AWAY Introducer 4FR x 5cm | 201.60.63.40V | EUDAMED | Class IIa | Active |
| PEEL-AWAY Introducer 3, 5FR x 5cm | 201.60.63.35 | EUDAMED | Class IIa | Active |
| PAINfusor Catheter 7, 5cm | 203.06.10.07T | EUDAMED | Class IIa | Active |
| PAINfusor Catheter 22, 5cm | 203.06.10.22T | EUDAMED | Class IIa | Active |
| HEALTHPICC Introducer Set 5, 5FR long - Long Guidewire | 201.60.51.15L | EUDAMED | Class IIa | Active |
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