Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610200

FEI Number

3002806986

Entity Name

FIDIA FARMACEUTICI SPA

City/State/Country

ABANO TERME Padova, IT

Establishment Address

VIA PONTE DELLA FABBRICA 3/A, ABANO TERME Padova 35031, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fidia Farmaceutici SPA (Owner Number: 9027294)

Owner / Operator Contact Address

VIA PONTE DELLA Fabbricia 3/A, Abano Terme, IT-PD 35031, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K963004

PMA Number

N/A

All Registered Proprietary Names

Hyalo GYN RICHPLAT ORTHO Platelet Rich Plasma System RICHPLAT ORTHO 40 PRP System RICHPLAT ORTHO 20 PRP System Hymovis One Hymovis Hyalgan Hyalo GYN Vaginal Moisturizing Suppositories Hyalo4 Care Clear Hydrogel Triluron Hyalo4 Care Hydrogel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2015-09-24
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2020-09-17
MOZ	Acid, Hyaluronic, Intraarticular	Unknown	Class 3	N/A	2015-09-16
MOZ	Acid, Hyaluronic, Intraarticular	Unknown	Class 3	N/A	2007-12-17
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2020-09-17
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2007-12-17
MOZ	Acid, Hyaluronic, Intraarticular	Unknown	Class 3	N/A	2019-09-20
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2007-12-17

Official Correspondent

No official correspondent registered.

US Agent Details

Vivian Kelly Email: vkelly@fidiapharma.us Phone: (973) 3094107

Related Public Records

Same Entity

Fidia Farmaceutici 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
K050212	Qualis, Inc.	PERSONAL WARMING JELLY	2005-03-17
K954741	Derma Sciences, Inc.	DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)	1995-11-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-05	DeRoyal Wound Care	U	Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part *SterileManufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA**

Similar Registrations

Registration Number	Establishment Name	Location
3012404174	LABORATORIO CHIMICO FARMACEUTICO A. SELLA SRL.	Schio Vicenza, IT
3040313889	SINGAPORE JOYHUB TECH PTE. LTD.	PREMIER @ KAKI BUKT North West, SG
2025292	COSMETIC ENTERPRISES, LTD.	PACOIMA, CA, US
3003631744	NATUREPLEX LLC	Olive Branch, MS, US
3009599096	WTFN INC. DBA CLASSIC EROTICA	Chatsworth, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610200. Last updated year: 2026. Please use registration number 9610200 when referencing this establishment in official correspondence.