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Autologous Cell Therapy

Autologous Vacutainers

All autologous blood-derived products are strictly regulated in Europe, to ensure the control of all the aspects related to preparations, storage, and distribution, and therefore the quality and safety of autologous treatments. The vacutainer used for PRP, PRF, i-PRF or any other autologous treatment must be licensed as a Class IIb Medical Device. 

A worrying number of practitioners are still using IVD tubes for autologous therapy. IVD tubes do not require any clinical evaluation process and they are not tested in the frame of biocompatibility. For this reason, IVD tubes are prohibited from clinical applications.

 

Smart Cell tubes are CE marked, Class IIb according to European Commission’s MEDDEV 93/42/EEC, Classification Document Annex IX with the Rule 3 that requires clinical evaluation and biocompatibility tests that lead to the permission of clinical applications.

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iPRF training

MEDICAL DEVICE

The i-PRF Smart Cell system uses biocompatible medical device (class IIb) tubes specifically designed for autologous therapy

100% NATURAL

 i-PRF Smart Cell system is 100% natural, completely free of chemicals, additives or clotting factors

Vacutainers

We offer 2 different kits.

Kit Option 1: contains 2 x 12ml tubes and will yield 4-8 ml of conditioned plasma. Kit price £45.00

Kit Option 2:  contains 4 x 12ml tubes and will yield 8-16 ml of conditioned plasma. Kit price £70.00

Note: conditioned plasma is client dependent. 

Treatment Kit Contents:

  • 2 x Blood collection 21G butterfly

  • 2 x Luer-lock 2.5ml syringe​

  • 2 x Meso-relle needle 30G x 4mm​

  • 2 x 30G 1 ½” sharp needle​

  • 2 x 30G x 13mm needle​

  • 12ml i-PRF Smart Cell vacutainers

i-PRF Smart Cell vacutainers (12ml) for Injectable Platelet Rich Fibrin (iPRF) in aesthetics.

Unlike other tubes, the Smart Cell vacutainers come in individual sterile blister packs.

Class IIb medical device.

The tubes comply with all regulatory requirements by the EU Directive 93/42/EEC (CE 0123).

Quantity: 24

Price: £145.00 +vat

iPRF Vacutainer

Medical Device EU Directive

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PRP Smart Cell vacutainers (12ml) for Platelet Rich Plasma & Plasma Filler in aesthetics.

The Smart Cell PRP vacutainers come in double sterile blister packs.

Class IIb medical device.

The tubes comply with all regulatory requirements by the EU Directive 93/42/EEC (CE 0123).

Quantity: 24

Price: £250.00 +vat

Compliance

Smart Cell tubes are CE0123, Class IIb Medical Device according to European Commission’s MEDDEV 93/42/EEC, Classification Document Annex IX with the Rule 3 that requires clinical evaluation and biocompatibility tests that lead to the permission of clinical applications.

IVD Vs MDD Tubes