Medical Device Registration

FDA Registration Number: 3004180226

Last Validated: April 25, 2024

Status: Valid

Valid2024 U.S. FDA Medical Device Establishment Registration

EUROPLAZ TECHNOLOGIES LTD.

Establishment Information

The Maltings Industrial Estate

Southminster Essex, GB CM07EQ

44-1621-773-471

quality@europlaz.co.uk

http://www.europlaz.co.uk

U.S. Agent and Official Correspondent

Registrar Corp

144 Research Drive

Hampton VA, USA 23666

+1-757-224-0177

info@registrarcorp.com

www.registrarcorp.com

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
Prosthesis, Hip, Hemi-, Femoral, Metal	KWL	Valid	April 24, 2024	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	April 24, 2024	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	April 24, 2024	Device Listing Device Name Forceps, Ophthalmic Product Code HNR Company Function(s) Contract Manufacturer Proprietary Name(s) BVI Visitec� Manipulators
Marker, Sclera	HMQ	Valid	April 24, 2024	Device Listing Device Name Marker, Sclera Product Code HMQ Company Function(s) Contract Manufacturer Proprietary Name(s) Beaver Visitec Internatlional Scleral Marker
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	Valid	April 24, 2024	Device Listing Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Product Code JDI Company Function(s) Contract Manufacturer Proprietary Name(s) C-STEM
Speculum, Vaginal, Nonmetal	HIB	Valid	April 24, 2024	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
Oral Administration Set	PXA	Valid	April 24, 2024	Device Listing Device Name Oral Administration Set Product Code PXA Company Function(s) Manufacturer Proprietary Name(s)

Valid2024 U.S. FDA Medical Device Establishment Registration

EUROPLAZ TECHNOLOGIES LTD.

Establishment Information

U.S. Agent and Official Correspondent

Listings on file with FDA

Device Listing

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