PLAN 1 HEALTH S.r.l.
IT-MF-000022746 · Italy · AMARO (UD)
PLAN 1 HEALTH S.r.l. is registered in the European database on medical devices as a manufacturer, with 73 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 73 |
|---|
Among these devices, 69 are declared sterile, 1 active.
Devices declared under this manufacturer
- AVATAR TIP LOCATOR BOX
- Echogenic needle 21GA micro 70mm
- HEALTHPICC Introducer Set 4,5FR long
- HEALTHPICC Introducer Set 5,5FR long
- Huber Needle 19GA – 1’’ with extension
- PAINfusor Catheter 15cm
- PAINfusor Catheter 22,5cm - 3X
- PAINfusor Catheter 22,5cm w/ filter
- PAINfusor Catheter 7,5cm w/ filter
- PEEL-AWAY Introducer 3,5FR x 5cm
- PEEL-AWAY Introducer 4FR x 5cm
- PEEL-AWAY Introducer 5,5FR x 5cm
Showing 12 of 73 declared devices.
Catalogue references include 201.60.51.15, 201.60.59.20, 201.60.60.14, 201.60.60.19, 201.60.63.35, 201.60.63.40.
European nomenclature codes declared: A03040199, C0503, C010280, A01010302, A019099, C04020299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 73 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 73 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | PLAN 1 HEALTH S.R.L. |
North American profile: Canada only. PLAN 1 HEALTH S.r.l. holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 045580 0028 | issued | 2029-02-04 |