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PLAN 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
Facebook
—
Phone
+390433468376
PRRC Contact
LUCA GIORGINI
EUDAMED SRN
IT-MF-000022746
FDA FEI Number
—
DUNS Number
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Catalogue (58)

Page 2 of 2
DeviceModel / ReferenceRegistriesClassStatus
PAINfusor Catheter 15cm 203.06.10.15T
EUDAMED
Class IIaActive
PEEL-AWAY Introducer 4FR x 5cm 201.60.63.40
EUDAMED
Class IIaActive
Straight Nitinol Mandrel Length 800mm Ø0, 445mm 201.60.60.14
EUDAMED
Class IIaActive
PEEL-AWAY Introducer 4FR x 5cm 201.60.63.40V
EUDAMED
Class IIaActive
PEEL-AWAY Introducer 3, 5FR x 5cm 201.60.63.35
EUDAMED
Class IIaActive
PAINfusor Catheter 7, 5cm 203.06.10.07T
EUDAMED
Class IIaActive
PAINfusor Catheter 22, 5cm 203.06.10.22T
EUDAMED
Class IIaActive
HEALTHPICC Introducer Set 5, 5FR long - Long Guidewire 201.60.51.15L
EUDAMED
Class IIaActive

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