Mediplus
Mediplus
Mediplus Ltd is a British manufacturer of medical devices for the areas of anaesthesiology, urology, urodynamics, and gynaecology. According to company documentation. Mediplus’s product range includes Capnomask™, Peripheral IV Connectors and TIVA Sets for use in Anaethesia; S-CathTM System, a suprapubic catheterisation device that incorporate the Seldinger technique, and POPYTM and MILEXTM Pessaries.
History
Mediplus was formed in 1986 by Bob Urie when the business originally focussed on Urodynamics catheters and accessories. The current leader of Mediplus is Emma Gray, who was appointed Managing Director in 2010 when Bob Urie, her father, moved to the role of Chairman.
According to the company website the Mediplus leadership team is comprised of the following, Emma Gray, Managing Director, James Urie, Global Marketing Director, Tim Ward, Director of Operations and Phil Cook, Director of Sales.
Regulatory Approvals and Certifications
Mediplus holds CE mark, ISO 13485 certification and has FDA approval for several products. Products are marketed throughout Europe, in the USA and Canada, South America, Australia, New Zealand and the Far East.
Authority/Standard |
Region |
Details |
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Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4 |
Europe |
Certificate scope. The design, development and manufacture of:
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ISO 13485:2016 & EN ISO 13485:2016 |
Europe |
Design, development, manufacture, sales and distribution of sterile devices:
Design, development, manufacture, sales and distribution of non-sterile devices:
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BSI EU 2023-607 Article 120 Confirmation Letter |
Europe |
Confirmation of the status of a formal application, written agreement, and appropriate surveillance in the framework of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. |
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UKCA certificate |
UK |
Certificate scope: The design, development and final inspection of: – Sterile and non-sterile rectal catheters for use in urodynamics – Sterile bladder catheters, for use in urology and urodynamics – Sterile and non-sterile administration sets, for use in urology, urodynamics and theatres – Sterile total intravenous anaesthesia (TIVA) sets, extension sets and peripheral connectors, for use within anaesthesiology, surgery, recovery and obstetrics – Non-sterile oxygen masks and Capnomasks, for oxygen delivery and monitoring of end tidal carbon dioxide – Non-sterile silicone shelf pessary, for use in gynaecology |
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FDA Establishment Registration & Device Listing |
US |
Establishment Registration & Device Listing FEI Number*: 3011308139 Registration Number: 9617192 |
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Device Listing for Catheter Accessories: |
US |
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Device Listing for Mediplus Urodynamics Sterile; Non-Sterile Catheters: |
US |
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Device Listing for S-Cath S-Cath |
US |
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Device Listing for Capnomask: Capnomask |
US |
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