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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
LinkedIn: linkedin.com/company/plan-1-health-srl
Facebook: —
Email: [email protected]
Phone: +390433468376
PRRC Contact: LUCA GIORGINI
EUDAMED SRN: IT-MF-000022746
FDA FEI Number: —
DUNS Number: —

Catalogue (58)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
PEEL-AWAY Introducer 5, 5FR x 7cm	201.60.63.55	EUDAMED	Class IIa	Active
PAINfusor Catheter 2, 5cm - 3X	203.06.10.02P3	EUDAMED	Class IIa	Active
Huber Needle 22GA – 0, 75’’ with extension	201.11.59.31	EUDAMED	Class IIa	Active
Straight Nitinol Mandrel Length 400mm Ø0, 445mm	201.60.60.10	EUDAMED	Class IIa	Active
Tunneler 165	201.11.62.55	EUDAMED	Class IIa	Active
PAINfusor Catheter 2, 5cm - 3X	203.06.10.02T3	EUDAMED	Class IIa	Active
PAINfusor Catheter 2, 5cm w/ filter	203.06.11.02P	EUDAMED	Class IIa	Active
PAINfusor Catheter 7, 5cm	203.06.10.07P	EUDAMED	Class IIa	Active
PAINfusor Catheter 30cm	203.06.10.30T	EUDAMED	Class IIa	Active
PAINfusor Catheter 22, 5cm - 3X	203.06.10.22P3	EUDAMED	Class IIa	Active
PAINfusor Catheter 15cm - 3X	203.06.10.15T3	EUDAMED	Class IIa	Active
PEEL-AWAY Introducer 4.5FR x 5cm	201.60.63.45	EUDAMED	Class IIa	Active
HEALTHPICC Introducer Set 4FR	201.60.51.03	EUDAMED	Class IIa	Active
PAINfusor Catheter 30cm - 3X	203.06.10.30T3	EUDAMED	Class IIa	Active
PAINfusor Catheter 22, 5cm	203.06.10.22P	EUDAMED	Class IIa	Active
Hand Filler	203.09.10.20	EUDAMED	Class I	Active
Huber Needle 22GA – 1’’ with extension	201.11.59.32	EUDAMED	Class IIa	Active
PAINfusor Catheter 15cm	203.06.10.15P	EUDAMED	Class IIa	Active
PEEL-AWAY Introducer 3FR x 7cm	201.60.63.34	EUDAMED	Class IIa	Active
PEEL-AWAY Introducer 4, 5FR x 7cm	201.60.63.46	EUDAMED	Class IIa	Active
Huber Needle 19GA – 0, 75’’ with extension	201.11.59.11	EUDAMED	Class IIa	Active
PEEL-AWAY Introducer 4, 5FR x 7cm	201.60.63.46V	EUDAMED	Class IIa	Active
Huber Needle 20GA – 1’’ with extension	201.11.59.22	EUDAMED	Class IIa	Active
HEALTHPICC Introducer Set 4, 5FR long - Long Guidewire	201.60.51.14L	EUDAMED	Class IIa	Active
PEEL-AWAY Introducer 4.5FR x 5cm	201.60.63.45V	EUDAMED	Class IIa	Active
Huber Needle 20GA – 0, 75’’ with extension	201.11.59.21	EUDAMED	Class IIa	Active
HEALTHPICC Introducer Set 4, 5FR short	201.60.51.04	EUDAMED	Class IIa	Active
Safety introducer needle 18GA x 70mm	201.51.59.11	EUDAMED	Class IIa	Active
PAINfusor Catheter 30cm - 3X	203.06.10.30P3	EUDAMED	Class IIa	Active
Tunneler 244	201.11.62.32	EUDAMED	Class IIa	Active
HEALTHPICC Introducer Set 6FR long	201.60.51.16	EUDAMED	Class IIa	Active
PAINfusor Catheter 7, 5cm - 3X	203.06.10.07P3	EUDAMED	Class IIa	Active
PAINfusor Catheter 7, 5cm - 3X	203.06.10.07T3	EUDAMED	Class IIa	Active
PEEL-AWAY Introducer 5, 5FR x 7cm	201.60.63.55V	EUDAMED	Class IIa	Active
Non-Sterile Open Slide Clamp	203.09.10.02	EUDAMED	Class I	Active
Open Slide Clamp	203.09.10.01	EUDAMED	Class I	Active
Echogenic needle 21GA micro 70mm	201.60.59.20	EUDAMED	Class IIa	Active
PAINfusor Catheter 2, 5cm	203.06.10.02T	EUDAMED	Class IIa	Active
HEALTHPICC Introducer Set 5, 5FR long	201.60.51.15	EUDAMED	Class IIa	Active
PEEL-AWAY Introducer 3FR x 5cm	201.60.63.30	EUDAMED	Class IIa	Active
PAINfusor Catheter 30cm	203.06.10.30P	EUDAMED	Class IIa	Active
PAINfusor Catheter 15cm - 3X	203.06.10.15P3	EUDAMED	Class IIa	Active
PAINfusor Catheter 7, 5cm w/ filter	203.06.11.07P	EUDAMED	Class IIa	Active
PAINfusor Catheter 22, 5cm - 3X	203.06.10.22T3	EUDAMED	Class IIa	Active
PEEL-AWAY Introducer 3, 5FR x 5cm	201.60.63.35V	EUDAMED	Class IIa	Active
Avatar Tip Locator Box	203.10.10.02	EUDAMED	Class I	Active
Huber Needle 19GA – 1’’ with extension	201.11.59.12	EUDAMED	Class IIa	Active
PAINfusor Catheter 22, 5cm w/ filter	203.06.11.22P	EUDAMED	Class IIa	Active
HEALTHPICC Introducer Set 4, 5FR long	201.60.51.14	EUDAMED	Class IIa	Active
PEEL-AWAY Introducer 5, 5FR x 5cm	201.60.63.54V	EUDAMED	Class IIa	Active

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