European Union
CE marking, an EU Declaration of Conformity, the test reports behind it, and an EU responsible-person address on the label and in the instructions.
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Compliance
The paperwork
before the purchase order
A quotation from us is not just a price. It carries the documents your market asks for, and you get to read them before you commit to anything.
What your market normally asks for
Requirements differ by destination — and by whether the device is sold as a massager or as a medical device. These are the sets buyers usually need; ask us for the one that applies to your model.
United Kingdom
UKCA marking and a UK Declaration of Conformity, with a UK responsible-person address. CE marking is still accepted in Great Britain for goods placed before the deadline for a given product type.
United States
FCC equipment authorisation for anything with a radio or a switching supply. Devices sold for a medical purpose also need their own FDA pathway — tell us the intended use and we will say plainly whether we can support it.
Everywhere else
IEC 60335 / 62133 safety and battery reports, RoHS and REACH material declarations, EMC reports and a material safety data sheet. Most national registrations are built on this set.
Certificates we hold
Each entry names the issuing body, the scope it covers and the number you can check with that body directly.
The document pack for the model you are considering is sent with the quotation — the actual files, not a logo.
What to ask any supplier for
Including us. A supplier who cannot produce these is telling you something.
The certificate itself, with a number you can search on the issuing body’s website
A Declaration of Conformity that names your exact model — not the series
Test reports behind the declaration, with the laboratory and the standard named
The scope: which directives, which standards, which variants are covered
Who the responsible person is in your jurisdiction, and where the address appears
Whether the device is declared as a medical device or as a consumer massager — the two paths are not interchangeable
Tell us the model and the market
We will come back with the documents that apply to it, and say plainly if something is not available yet.