Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003805036

FEI Number

3003805036

Entity Name

PLASTIAPE S.p.A

City/State/Country

Osnago Lecco, IT

Establishment Address

via I Maggio, 8, Osnago Lecco 23875, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Plastiape S.p.A (Owner Number: 10051411)

Owner / Operator Contact Address

via I Maggio, 8, Osnago, IT-LC 23875, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Promacta Inhaler

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2025-04-09
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2016-03-14

Official Correspondent

No official correspondent registered.

US Agent Details

Gina Walljasper Business: GPW Enterprises LLC Email: gina@walljasperpc.com Phone: (908) 5076503

Related Public Records

Same Entity

Plastiape S.p.A

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003805036. Last updated year: 2026. Please use registration number 3003805036 when referencing this establishment in official correspondence.