Mytocel MSKUnited Kingdom
A protocol booklet, a binder, a sealed single-use device and gloves on a desk

Regulatory information

Product status, manufacturer and UK supply.

Mytocel MSK® is a CE-marked medical-device system registered with the MHRA and supplied in the United Kingdom exclusively by Actomed. This page states what is on the record and what registration does and does not mean.

Intended use

What the system is for.

Mytocel MSK is used by trained clinicians to prepare a suspension of autologous cartilage micrografts from a small auricular sample for administration to a joint in the same session.

Descriptive statement; the instructions for use take precedence.

Devices and classification

Two devices, two classes.

DeviceClassNotes
Rigeneracons® RSClass IIasterile, single-use
Rigenera® N4SAClass Ireusable processing unit
The N4SA processing unit photographed on a white background
N4SA processing unit
The single-use Rigeneracons RS device photographed on a white background
Rigeneracons RS, sterile single-use device

Manufacturer and UK Responsible Person

Who makes it and who answers for it in the UK.

Manufacturer
Human Brain Wave srl, Turin, Italy, part of the Remedi group
UK Responsible Person
yoursciencebc limited, Walton-on-Thames
MHRA registration
Registered with the MHRA. Registration is not approval.1
Conformity
CE marked; accepted on the Great Britain market under current transitional arrangements.
Exclusive UK supplier
Actomed Ltd, Grantham, Lincolnshire

Registration is not approval

The MHRA registers medical devices placed on the Great Britain market; it does not approve them. Conformity marking shows the device meets the requirements for its intended purpose. Neither is evidence for any efficacy claim, which is why every clinical statement on this site carries its study and its limitations.

Vigilance

Report incidents and complaints.

Report a suspected incident or product complaint to Actomed, which forwards it to the manufacturer.

Report to Actomed

Document control

Dates, references and precedence.

Date of preparation: September 2026.

Website content is orientation only. The current instructions for use, professional protocol and training take precedence.2

The healthcare professional section is intended for UK healthcare professionals. The patient section is general information and not medical advice.

References

  1. 1.Medicines and Healthcare products Regulatory Agency. Public Access Registration Database (PARD), medical device registrations. View source
  2. 2.Remedi (Regenera Activa). Mytocel MSK professional protocol. Manufacturer document. View source

Questions about status or supply?

Actomed can confirm current documentation, territory requirements and registration details for your clinic.

Contact ActomedProfessional resources