Certifications
Derma Pen Certifications and Compliance
TBPHP products are CE marked, UKCA documented, and RoHS compliant. TBPHP does not publicly claim FDA approval, FDA registration, FDA clearance, MDR certification, or MDR compliance.
- CE marked
- UKCA documented
- RoHS compliant
- No public FDA or MDR certification claim
Certifications and Regulatory Compliance
TBPHP products are CE marked, UKCA documented and RoHS compliant. TBPHP maintains active certifications that cover design, manufacturing, and sterilization of microneedling devices and components. All certifications are current and available for customer review upon request.
CE Marking
All TBPHP microneedling devices and cartridges carry CE marking, confirming conformity with applicable EU health, safety, and environmental requirements. Our technical files are maintained and updated to reflect current regulatory standards. CE marking applies to all standard cartridge models and electric pen systems.
UKCA Certification
TBPHP products are assessed for UKCA (UK Conformity Assessed) marking, meeting the regulatory requirements for placing microneedling devices on the Great Britain market. Our UKCA documentation includes technical file review, conformity assessment, and UK Responsible Person registration.
RoHS Compliance
All TBPHP products comply with RoHS (Restriction of Hazardous Substances) Directive 2011/65/EU and its amendments. Materials used in cartridge production – including stainless steel needles, polypropylene hubs, and packaging components – are tested and certified to be free of restricted substances including lead, mercury, cadmium, hexavalent chromium, PBBs, and PBDEs. RoHS declarations are available per batch upon request.
Sterilization Certification
All sterile microneedling cartridges are processed through validated EO sterilization cycles per ISO 11135. Sterilization validation packages and batch-level certificates of sterility are available upon request.
Quality Assurance
TBPHP operates four automated production lines. Each production batch is documented with 47-point inspection records and statistical process control data. Our quality management system covers incoming material inspection, in-process quality control, final inspection, and batch traceability.
Certification documents, test reports, and declarations of conformity are available upon request. Contact our regulatory team for specific documentation needs.