Is your bioresonance machine a registered medical device?
Most are not.
There is no rule stopping anyone importing a box with electrodes, calling it bioresonance and selling it in the UK. A great many suppliers do exactly that. The device is not a registered medical device, the seller is not registered with the MHRA, and there is no UK Responsible Person standing behind it. If it fails, or if a client asks your insurer an awkward question, there is nobody to point at.
That distinction rarely comes up in a sales conversation, because the supplier selling an unregistered device has no reason to raise it.
What registration actually means
A medical device sold in Great Britain has to be registered with the Medicines and Healthcare products Regulatory Agency. If the manufacturer is outside the UK, a UK Responsible Person has to be named on that registration and is accountable here for the device.
Registration is not a quality award. It means the manufacturer has declared conformity against a standard, the paperwork exists, and there is a named party the regulator can reach. That is a low bar. It is worth knowing how many devices do not clear it.
Where the BICOM optima sits
The BICOM optima therapy device with EAP test part (B32) and the BICOM optima mobil (BM34) are Class IIa medical devices, registered with the MHRA for the Great Britain market.
- UK Responsible Person: LFH Regulatory Limited, Leeds
- Registration runs to 12 September 2029
- CE marked under directive 93/42/EEC, carried forward under Article 120 of EU MDR 2017/745
- Declaration of conformity dated 6 August 2024
- Legal manufacturer: AC Aircontrols GmbH, Kempen, Germany
Certificates are available on request. Ask us and we will send them.
What to ask any supplier before you buy
Four questions. Any supplier of a registered device can answer all four in a sentence.
- Is the device registered with the MHRA, and under what class?
- Who is the UK Responsible Person, and what is their registered address?
- When does the registration expire?
- Can I see the certificate?
If the answers are vague, or the reply explains why registration is not necessary in this case, you have your answer.
What this does not mean
Registration is about the device, not about outcomes. The only substantiated claim for BICOM bioresonance therapy is the treatment of allergies and the lessening of allergic reactions. Clinical trials for this non-invasive therapy still need to be conducted, and that work is ongoing in a number of countries.
Other products we supply, including the BodyBalanceCheck and the QuintStation, are separate products with their own status and are not covered by the registration above.