Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014165712

FEI Number

3014165712

Entity Name

PIKDARE S.p.A.

City/State/Country

Casnate con Bernate Como, IT

Establishment Address

Via Saldarini Catelli 10, Casnate con Bernate Como 22070, IT

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

PIKDARE S.P.A. (Owner Number: 10056365)

Owner / Operator Contact Address

Via Saldarini Catelli 10, Casnate con Bernate, IT-CO 22070, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K052667

PMA Number

N/A

All Registered Proprietary Names

DropSafe Sicura Safe Block Pen Needle ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES DROPLET PEN NEEDLE G34 INSUPEN PEN NEEDLE Droplet 33G / Droplet 34G / Droplet 30G / Leader 33G DROPLET PEN NEEDLE G33 DROPLET PEN NEEDLE G30 LEADER PEN NEEDLE G33 ARTSANA PISTON AND INSULIN SYRINGES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-12-20
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-12-01
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-12-01
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2017-12-01

Official Correspondent

Paola Branchi

US Agent Details

Sylvie Verdon Business: HTL-Strefa, Inc. Email: sylvie.verdon@htl-strefa.com Phone: (770) 5280410

Related Public Records

Same Entity

PIKDARE S.P.A.

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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

Similar Registrations

Registration Number	Establishment Name	Location
3027338968	RONCADELLE OPERATIONS SRL	Castel Mella Brescia, IT
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3006850123	JAPAN IRRADIATION SERVICE CO., LTD	Naka-gun Ibaraki, JP
3029328631	PEGASUS IMPORTS	Houston, TX, US
3010621964	ATLAS MEDICAL PRODUCTS LLC	Hialeah, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014165712. Last updated year: 2026. Please use registration number 3014165712 when referencing this establishment in official correspondence.