Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009853488

FEI Number

3009853488

Entity Name

U-NEEDLE B.V.

City/State/Country

Enschede Overijssel, NL

Establishment Address

De Veldmaat 10, Enschede Overijssel 7522 NM, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

U-Needle BV (Owner Number: 10080399)

Owner / Operator Contact Address

De Veldmaat, 10, Enschede, NL-OV 7522NM, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190962

PMA Number

N/A

All Registered Proprietary Names

Bella-mu

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	2021-01-29

Official Correspondent

Jeroen Wissink

US Agent Details

Robert Packard Business: Medical Device Academy Incorporated Email: rob@fdaestar.com Phone: (802) 2581881

Related Public Records

Same Entity

U-Needle BV

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 3009853488. Last updated year: 2026. Please use registration number 3009853488 when referencing this establishment in official correspondence.