Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004180226

FEI Number

3001598088

Entity Name

EUROPLAZ TECHNOLOGIES LTD.

City/State/Country

Southminster Essex, GB

Establishment Address

The Maltings Industrial Estate, Southminster Essex CM07EQ, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Europlaz Technologies Ltd. (Owner Number: 10042366)

Owner / Operator Contact Address

The Maltings Industrial Estate, Southminster, GB-ESS CM07EQ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Quadsense Beaver Visitec Internatlional Scleral Marker Endocuff Vision EndoSign® Cell collection device C-STEM C-STEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ONN	Intraoperative Orthopedic Joint Assessment Aid	Neurology	Class 2	882.4560	2025-01-07
HMQ	Marker, Sclera	Ophthalmic	Class 1	886.4570	2016-08-17
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-01-07
EOX	Esophagoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4710	2026-02-27
PXA	Oral Administration Set	General Hospital	Class 1	880.6430	2024-03-20
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-01-24
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-01-24

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Europlaz Technologies Ltd.

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
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15
K940328	Orthopaedic Innovations, Inc.	PRIME CEMENTED HIP SYSTEM	1995-04-07
K950761	Biomet, Inc.	INDEX ACETABULAT COMPONENT	1995-05-02
K972928	Howmedica, Inc.	KERBOULL CROSS	1997-11-03
K830313	Biomet, Inc.	CFE TOTAL HIP FEMORAL COMPONENT	1983-05-25

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3013756293	IMMETECH INDUSTRIAL CO.,LTD	Dongguan City Guangdong, CN
3033434191	EVENTUM ORTHOPAEDICS LTD	Leeds, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004180226. Last updated year: 2026. Please use registration number 3004180226 when referencing this establishment in official correspondence.