Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617192

FEI Number

3011308139

Entity Name

MEDIPLUS LTD.

City/State/Country

HIGH WYCOMBE, BUCKS Buckinghamshire, GB

Establishment Address

UNIT 7 THE GATEWAY CENTRE, CORONATION RD CRESSEX BUS. PK., HIGH WYCOMBE, BUCKS Buckinghamshire HP12 3SU, GB

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

MEDIPLUS LTD. (Owner Number: 9041147)

Owner / Operator Contact Address

UNIT 7 THE GATEWAY CENTRE, CORONATION RD. CRESSEX BUS.PK., HIGH WYCOMBE, GB-BKM HP12 3SU, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K131339

PMA Number

N/A

All Registered Proprietary Names

S-Cath NON-STERILE CATHETERS MEDIPLUS URODYNAMICS STERILE Capnomask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOB	Catheter, Suprapubic (And Accessories)	Gastroenterology, Urology	Class 2	876.5090	2014-02-28
FEN	Device, Cystometric, Hydraulic	Gastroenterology, Urology	Class 2	876.1620	2002-01-08
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2014-02-28

Official Correspondent

EMMA GRAY

US Agent Details

Matt Dryden Business: Promedic, LLC Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

MEDIPLUS 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
K132890	Mediplus , Ltd.	SUPRAPUBIC CATHETER AND INTRODUCER SET	2014-01-17
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

Similar Registrations

Registration Number	Establishment Name	Location
3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK
1718873	UTAH MEDICAL PRODUCTS, INC.	Midvale, UT, US
3030446844	PLATINUM FOCUS GROUP LTD.	London London, City of, GB
1825146	Cook Incorporated	Spencer, IN, US
3030733800	AD SUPPLY GROUP LIMITED	London London, City of, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617192. Last updated year: 2026. Please use registration number 9617192 when referencing this establishment in official correspondence.