Medical device

"Medical devices have to grant a high-level protection for patients, users and third. They also have to perform services stated from the manufacturer."


Dear prospective buyer!

Many thanks for your interests in our diagnostic-system.

NLS – Diagnostic-systems are a unique possibility of diagnosis. The system achieves a lot and the price is affordable.


Which NLS – Diagnostic-system should a physician buy?

In the area of the NLS- (Non Linear System) diagnostic, the Oberon system 4021, which we produce in Hamburg, is the only System with a medical device allowance!


Why is this allowance necessary?

If you are a physician or a traditional healer and you use diagnostic-devices in your medical practice upon your patients, this device needs to have a medical device allowance. This allowance has to accord with the regulations of the MPG (Medizin Produkte Gesetz (medical device law)). This means that all allowances and certifications from the outside of the European Union are not valid within the European Union.


What happens if I nevertheless buy a non-certified System and use it upon my patients?

If you use a medical device on humans which is not allowed in the EU, incurs a penalty and in the case of regress your insurance will not pay the costs for potential consequences of an examination. It is also possible that the device used for the examination is seized from the administration and there are high penalties. In very massive cases this can also lead to a ban from profession.

Therefore you should always look after the allowance first when you buy a medical product. The verification of this allowance is a valid declaration of conformity. After that you can look after the capacity and last after the price
 

What can I do, if I already bought a non-certified device?

Claim from your sales person the immediate retraction. If he refuses the retraction you can tell on this sales person to us We will then forward him to the administration for environment and health, dept. consumer protection – medical products of your federal state.

Klaus Valentiner