Medical device information
Product status and professional-use boundaries.
Always verify current manufacturer documentation and territory requirements before ordering or clinical use.
Supplied documentation
The supplied professional material describes the reusable processing machine as a Class I medical device and Rigeneracons® RS as a sterile, single-use Class IIa medical device.
Not an MHRA approval claim
Registration or conformity marking must not be described as product “approval” by the MHRA. Appropriate conformity status also does not by itself substantiate every efficacy claim.
Great Britain and Northern Ireland
Different regulatory requirements apply in Great Britain and Northern Ireland. Confirm the clinic’s territory, current labelling, registration and applicable conformity marking before supply.
Manufacturer and responsible-person information
The exact manufacturer, responsible-person, importer and registration information should be taken from the current product label, declaration and formal supply documentation—not inferred from marketing copy.
Incidents and complaints
For a product quality complaint or suspected incident, contact [email protected] and follow applicable clinic, manufacturer and MHRA reporting processes. For urgent medical situations, use local emergency procedures.
Current UK guidance: MHRA — regulating medical devices in the UK ↗.