Draft:Mediplus

  • Comment: This is just a corporate brochure. We want to see what secondary sources have said about this business and what in their opinion makes it worthy of note. DoubleGrazing (talk) 13:48, 9 April 2026 (UTC)


Mediplus Ltd is a British manufacturer of medical devices for the areas of anaesthesiology, urology, urodynamics, and gynaecology. Mediplus’s product range includes

According to UK Healthcare Pavilion website run by the ABHI and DBT, Mediplus "develops a wide range of innovative, patient centred medical devices, exporting to over 40 countries".[1]

Mediplus
Company type
Private
IndustryMedical Device
Founded1986
FounderBob Urie
HeadquartersHigh Wycombe, UK
Area served
Worldwide
Key people
Emma Gray, Managing Director, James Urie, Global Marketing Director, Tim Ward, Director of Operations and Phil Cook, Director of Sales.
ProductsCapnomask™, Peripheral IV Connectors, TIVA Sets, POPY™ and MILEX® Pessaries, S-Cath System
Number of employees
50+
Websitehttps://mediplusuk.com/

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.

Mediplus was awarded the Queens Award for International Trade in 2013 and for Enterprise in 2017[1]. The 2013 International Trade Award recognised a 105% increase in overseas sales over six consecutive years.[2] The 2017 Innovation Award was granted for the development of the S‑Cath™ System’s patented guide wire technique, enabling suprapubic catheterisation to be performed as an outpatient procedure rather than a two-day inpatient admission, and reducing associated complication risks.[3][4]

Independent clinical research

Several published studies have explored the role of Mediplus products in care settings.

  • A new model for suprapubic catheterization: the MediPlus Seldinger suprapubic catheter[5]
  • McMeekin, McCormick and MacDonagh reported in Continence UK, 2010, Vol 4, No1 that when using the S-Cath™ System procedure time was 28 minutes compared to an average duration of stay of 2.3 days[6]
  • 75% S-Cath™ System inserted in sub-acute / ASC using local anaesthetic[6]
  • Vasdev, N. et al. assessed the MediPlus suprapubic Foley catheter introduction set in six patients using the Seldinger technique, finding that clinicians expressed greater confidence in application, patient comfort and safety compared to standard trocar placement.[7]
  • In 2021, the S‑Cath™ System was adopted by interventional radiologists across Texas. Independent reporting noted a 40.75% reduction in catheter-acquired urinary tract infections (CAUTI) when using the device, and a reduction in procedure duration to under 29 minutes compared to an average inpatient stay of 2.3 days.[8]

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
Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4[9] Europe Certificate scope. The design, development and manufacture 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;
  • Sterile vascular ligation/occlusion loops, for use in surgery;
  • Oxygen masks and Capnomasks, for oxygen delivery and monitoring of end tidal carbon dioxide;
  • Non-sterile Silicone Shelf Pessary, for use in gynaecology;
  • Sterile Silicone, 3 way catheter, for use in urology.
ISO 13485:2016 & EN ISO 13485:2016[10] Europe Design, development, manufacture, sales and distribution of sterile devices:
  • Anaesthesia systems including administration sets and peripheral connectors;
  • Catheters;
  • Irrigation and extension sets;
  • Drainage systems;
  • For the areas of anaesthesiology, urology, urodynamics, obstetrics, theatres, recovery and surgery.

Design, development, manufacture, sales and distribution of non-sterile devices:

  • Capnography and oxygen masks;
  • Catheters;
  • Silicone pessary;
  • Penile cuffs;
  • For the areas of anaesthesiology, urology, urodynamics and gynaecology.
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.
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

FDA Establishment Registration & Device Listing US Establishment Registration & Device Listing

FEI Number*: 3011308139 Registration Number: 9617192[11]

Device Listing for Catheter Accessories: US
Owner/Operator Number: 9041147
Establishment Operations: Foreign Exporter; Specification Developer; Complaint File Establishment[12]
Device Listing for Mediplus Urodynamics Sterile; Non-Sterile Catheters: US
Owner/Operator Number: 9041147
Establishment Operations: Foreign Exporter; Specification Developer; Complaint File Establishment[13]
Device Listing for S-Cath S-Cath US
Owner/Operator Number: 9041147
Establishment Operations: Foreign Exporter; Manufacturer; Specification Developer; Complaint File Establishment[14]
Device Listing for Capnomask: Capnomask US
Owner/Operator Number: 9041147
Establishment Operations: Foreign Exporter; Specification Developer; Complaint File Establishment[15]

Regulatory Guidance and briefing

NICE published guidance for the Mediplus S‑Cath System for suprapubic catheterisations on 10 June 2016. The guidance states that "The S‑Cath System is intended for use in people for whom a suprapubic catheter is indicated, and differs from conventional suprapubic catheters because a guidewire (the Seldinger technique) is used for improved placement."[16]

The NHS Technology Adoption Center provided a published a briefing pack for the Mediplus S-Cath System covering the technology, the evidence, the financial case and feedback from NHS sites. The executive summary of the document reported "The system helps to reduce the number of complications associated with supra-pubic catheterisation, is safer for patients and can produce cost savings for NHS Trusts. The transfer of the procedure from an inpatient to an outpatient setting can benefit patients and can dramatically reduce the associated length of stay."[17]

References

  1. ^ a b "Mediplus - Developing innovations that improve patient care". UK Healthcare Pavilion. 2021-01-07. Retrieved 2026-02-10.
  2. ^ The Queen’s Awards for Enterprise 2013 Press Book: International Trade. The Gazette. 21 April 2013. Available at: https://www.thegazette.co.uk/content/pdf/2013_winners_of_the_Queen_s_Awards_for_Enterprise__press_book.pdf (Accessed: 9 April 2026).
  3. ^ The Queen’s Awards for Enterprise 2017 Press Book: Innovation. The Gazette. 21 April 2017. Available at: https://www.thegazette.co.uk/content/pdf/2017_Queen%27s_Awards_Press_Book.pdf (Accessed: 9 April 2026).
  4. ^ "Mediplus wins Queen's Award for Enterprise: Innovation for pioneering 'bladder GPS'". Buckinghamshire Business First. Retrieved 2026-04-09.
  5. ^ Mohammed, Aza; Khan, Azhar; Shergill, Iqbal S; Gujral, Sandy S (2008-11-01). "A new model for suprapubic catheterization: the MediPlus Seldinger suprapubic catheter". Expert Review of Medical Devices. 5 (6): 705–707. doi:10.1586/17434440.5.6.705. ISSN 1743-4440.
  6. ^ a b "Introducing a new technique for suprapubic catheterisation". Continence UK. 4 (1). 2010.
  7. ^ Vasdev, N., Kachroo, N., Mathur, S. and Pickard, R. (2006) ‘Suprapubic bladder catheterisation using the Seldinger technique’. Internet Journal of Urology, 5(1). Available at: http://ispub.com/IJU/5/1/4324 (Accessed: 9 April 2026).
  8. ^ Davies, Sophie (2021-04-09). "Award winning S-Cath system to be used across Texas to improve patient safety". Lifescience Industry News. Retrieved 2026-04-09.
  9. ^ "Client Directory Certificate". BSI. Retrieved 2026-02-05.
  10. ^ "Client Directory Profile". BSI. Retrieved 2026-02-05.
  11. ^ "Establishment Registration & Device Listing". www.accessdata.fda.gov. Retrieved 2026-02-05.
  12. ^ "Establishment Registration & Device Listing". www.accessdata.fda.gov. Retrieved 2026-02-05.
  13. ^ "Establishment Registration & Device Listing". www.accessdata.fda.gov. Retrieved 2026-02-05.
  14. ^ "Establishment Registration & Device Listing". www.accessdata.fda.gov. Retrieved 2026-02-05.
  15. ^ "Establishment Registration & Device Listing". www.accessdata.fda.gov. Retrieved 2026-02-05.
  16. ^ "Overview | S-Cath System for suprapubic catheterisation | Advice | NICE". www.nice.org.uk. 2016-06-10. Retrieved 2026-02-10.
  17. ^ "S-Cath™ Supra-Pubic Foley Catheter Introduction Set Mediplus Limited" (PDF). NHS Technology Adoption Centre.

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