FDA Registration Number: 3004180226

Last Validated: February 19, 2025

Status: Valid

Valid2025 U.S. FDA Medical Device Establishment Registration

EUROPLAZ TECHNOLOGIES LTD.

Establishment Information

The Maltings Industrial Estate
Southminster Essex, GB CM07EQ

U.S. Agent and Official Correspondent

Registrar Corp
144 Research Drive
Hampton VA, USA 23666
Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by U.S. FDA.

Listings on file with FDA

Device Name Product Code Status Last Validated  
Intraoperative Orthopedic Joint Assessment Aid ONN Valid February 18, 2025

Device Listing

Device Name

Intraoperative Orthopedic Joint Assessment Aid

Product Code

ONN

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Quadsense
Prosthesis, Hip, Hemi-, Femoral, Metal KWL Valid February 18, 2025

Device Listing

Device Name

Prosthesis, Hip, Hemi-, Femoral, Metal

Product Code

KWL

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

PFC
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI Valid February 18, 2025

Device Listing

Device Name

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Product Code

JDI

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

C-STEM
Forceps, Ophthalmic HNR Valid February 18, 2025

Device Listing

Device Name

Forceps, Ophthalmic

Product Code

HNR

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

BVI Visitec� Manipulators
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI Valid February 18, 2025

Device Listing

Device Name

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Product Code

JDI

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

C-STEM
Marker, Sclera HMQ Valid February 18, 2025

Device Listing

Device Name

Marker, Sclera

Product Code

HMQ

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Beaver Visitec Internatlional Scleral Marker
Speculum, Vaginal, Nonmetal HIB Valid February 18, 2025

Device Listing

Device Name

Speculum, Vaginal, Nonmetal

Product Code

HIB

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Disposable Treatment Pipe
TRP001-Disposable Treatment RPE
DSP003 - Small Disposable Speculum
DSP001 - Small Disposable Speculum
DSP002 - Small Disposable Speculum
Endoscopic Access Overtube, Gastroenterology-Urology FED Valid February 18, 2025

Device Listing

Device Name

Endoscopic Access Overtube, Gastroenterology-Urology

Product Code

FED

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Endocuff Vision
Oral Administration Set PXA Valid February 18, 2025

Device Listing

Device Name

Oral Administration Set

Product Code

PXA

Company Function(s)

Manufacturer

Proprietary Name(s)

Tube, Collection, Capillary Blood GIO Valid February 18, 2025

Device Listing

Device Name

Tube, Collection, Capillary Blood

Product Code

GIO

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Drawmore finger blood collection device

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