Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617582

FEI Number

3003272824

Entity Name

PIETRASANTA PHARMA S.P.A.

City/State/Country

C.F e P.IVA Lucca, IT

Establishment Address

VIA di Caprino 7, 55012 Capannori (LU), C.F e P.IVA Lucca 0119403046, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PIETRASANTA PHARMA SpA (Owner Number: 9044545)

Owner / Operator Contact Address

VIA S. FRANCESCO NO. 67, --, VIAREGGIO, IT-LU 55049, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ortopad Ortolux Ortolux Ortopad Hydrogel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2003-09-10
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2001-01-29
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2020-01-10

Official Correspondent

No official correspondent registered.

US Agent Details

Lindy van Dalen Business: Optego Vision USA, Inc. Email: lindy@optego.com Phone: (520) 6174490

Related Public Records

Same Entity

PIETRASANTA PHARMA SpA

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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Similar Registrations

Registration Number	Establishment Name	Location
3009662219	Custom Medical and Safety Products Inc.	Buffalo, NY, US
3014553350	CORRECT BREATHING CONCEPTS, LLC	Painesville, OH, US
3023122974	MBET HEALTH, LLC	Tarzana, CA, US
3012453673	FANNIN (UK) LIMITED	Measham, Swadlincote Derbyshire, GB
3019843433	The Natural Patch Company Pty Ltd	Prahran Victoria, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617582. Last updated year: 2026. Please use registration number 9617582 when referencing this establishment in official correspondence.