Medical device information
Medical device information for Bioport TriCombo.
The manufacturer, conformity, intended purpose, formats and vigilance route for Bioport TriCombo.
Manufacturer
Manufactured by Rompharm for the Bioport brand.
Bioport TriCombo is manufactured by S.C. Rompharm Company S.R.L., Romania, and sold under the Bioport brand of Nikovari Bio Tech Oy, Finland. UK Responsible Person: Actomed Ltd, The Old Barracks, Sandon Road, Grantham NG31 9AX.
Conformity
Registered with the MHRA.
Bioport TriCombo is registered with the MHRA as a Class III medical device (synovial fluid supplementation medium), with Actomed Ltd as UK Responsible Person. Registration with the MHRA is not an approval or endorsement of the device. The packaging carries a CE mark. Current instructions for use remain authoritative.
Intended purpose
As stated by the manufacturer.
The instructions for use indicate TriCombo for synovial joints. The manufacturer’s brochure gives the knee as its example: ‘As a viscoelastic supplement or as a replacement for the synovial fluid in the knee joint’ and ‘For the symptomatic treatment of mild to severe knee osteoarthritis’. The knee is the only joint with a published study of the formulation.
The manufacturer describes the intended effects as pain relief, lubrication and mechanical support, and protection and regeneration of the cartilage. These are the manufacturer’s statements; individual results vary.
Formats
Format and presentation.
| Property | Value |
|---|---|
| Formats | 2.25 ml pre-filled syringe |
| Presentation | Supplied as a single-use, pre-filled 2.25 ml glass syringe (Becton Dickinson), sterile, for intra-articular injection. |
| Treatment schedule | One syringe per treatment. The manufacturer recommends two treatment cycles per year, at six-month intervals. |
Information on this site
Two sections, written for two audiences.
Product and clinical-evidence information on this site is written for UK healthcare professionals. Patients should discuss whether TriCombo is suitable with a treating clinic. The patient section gives general information for patients. It is not clinical advice and does not replace an assessment by a clinician.
The professional section covers composition, indications, contraindications, handling and evidence. Current instructions for use remain authoritative.
Vigilance
Reporting a suspected adverse event.
Report any suspected adverse event to the treating clinic and to the UK supplier, quoting the lot number from the pack. The supplier passes reports to the manufacturer.