Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010600155

FEI Number

3010600155

Entity Name

VIROCLINICS BIOSCIENCES B.V.

City/State/Country

Rotterdam Zuid-Holland, NL

Establishment Address

Marconistraat 16, Rotterdam Zuid-Holland 3029 AK, NL

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

NJK & Associates (Owner Number: 10045793)

Owner / Operator Contact Address

Marconistraat 16, Rotterdam, NL-ZH 3029 AK, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hygiene Mask - 2PLY-WHITE-EARLOOPS UTM Tubes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2013-12-30
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2013-12-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-09-13
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2018-10-02
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	Class 2	862.1675	2021-02-01

Official Correspondent

Natalie Kennel

US Agent Details

Natalie Kennel Business: NJK & Associates & Inc. Email: nkennel@njkconsulting.com Phone: (858) 7050350

Related Public Records

Same Entity

NJK & Associates

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
K914894	Microtest	VIRAPURE, CHLAMYPURE AND MYCOPURE	1991-12-18
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
K981039	Sri Johani Sdn. Bhd.	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	1998-04-21

Similar Registrations

Registration Number	Establishment Name	Location
9680454	EMPRESAS IAI S DE RL DE C.V.	H. MATAMOROS Tamaulipas, MX
3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010600155. Last updated year: 2026. Please use registration number 3010600155 when referencing this establishment in official correspondence.