Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010280735

FEI Number

3010280735

Entity Name

VACUTEST KIMA SRL

City/State/Country

ARZERGRANDE Padova, IT

Establishment Address

VIA DELL'INDUSTRIA 12, ARZERGRANDE Padova 35020, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VACUTEST KIMA Srl (Owner Number: 10043026)

Owner / Operator Contact Address

VIA DELL'INDUSTRIA 12, ARZERGRANDE, IT-PD 35020, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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	2021-12-27
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2013-01-21

Official Correspondent

No official correspondent registered.

US Agent Details

Lorenzo Da Madice Business: ISOPLAN USA Email: isoplan@fda-510k.com Phone: (386) 8680618

Related Public Records

Same Entity

VACUTEST KIMA Srl

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010280735. Last updated year: 2026. Please use registration number 3010280735 when referencing this establishment in official correspondence.