Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006188722

FEI Number

3006188722

Entity Name

Plan 1 Health SRL

City/State/Country

Amaro Udine, IT

Establishment Address

Via Solari 5, Amaro Udine 33020, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Plan 1 Health, S.r.l. (Owner Number: 10037694)

Owner / Operator Contact Address

Via Solari 5, Amaro, IT-UD 33020, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111031

PMA Number

N/A

All Registered Proprietary Names

Painfusor Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2011-08-08

Official Correspondent

Sigi Caron

US Agent Details

Sigi Caron Email: sigi@bioMDG.com Phone: (310) 6143120

Related Public Records

Same Entity

Plan 1 Health, S.r.l.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K072702	Stryker Instruments, Instruments Div.	STRYKER ANTIMIC CATHETER	2008-03-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006188722. Last updated year: 2026. Please use registration number 3006188722 when referencing this establishment in official correspondence.