Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006999064

FEI Number

3006999064

Entity Name

PIERREL S.P.A.

City/State/Country

Capua Caserta, IT

Establishment Address

Strada Statale Appia 7 bis 46/48, Capua Caserta 81043, IT

Establishment Type(s)

Foreign Private Label Distributor

Owner / Operator

PIERREL S.P.A. (Owner Number: 10050470)

Owner / Operator Contact Address

Strada Statale Appia 7 bis 46/48, Capua, IT-CE 81043, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

G.o.c.c.l.e.s. light G.o.c.c.l.e.s. Prism Safety Capsule System Orabloc - needle stick safety system

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NXV	Diagnostic Light, Soft Tissue Detector	Dental	Class 2	872.6350	2015-11-20
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-10-12

Official Correspondent

Fabio Velotti

US Agent Details

Katie Doane Email: katie@usagent-tobias.com Phone: (716) 2208726

Related Public Records

Same Entity

PIERREL 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

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

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2018957	DEN-MAT HOLDINGS, LLC	Lompoc, CA, US
3005515469	DENTLIGHT INC.	Plano, TX, US
3010143501	FORWARD SCIENCE TECHNOLOGIES LLC	Houston, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006999064. Last updated year: 2026. Please use registration number 3006999064 when referencing this establishment in official correspondence.