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. Documentation must be reviewed against the exact product model and target market. Existing product documents must not be assumed to cover a new model, accessory, or product category.
CE Marking
For a CE-marked product, request the documentation associated with the specific model you intend to order. Confirm that the product name, model, applicable requirements, and document details match your sourcing project.
UKCA Marking
Request the UKCA documentation for the selected product and review its stated model and market scope. Do not assume a document for one device or cartridge applies to another model.
RoHS Compliance
Request the RoHS documentation relevant to the selected product. Review the named model, tested materials or components, and report scope rather than assuming the same report covers every item in the catalogue.
Cartridge Sterilization Documentation
For a cartridge supplied as sterile, confirm the sterilization information, packaging label, and supporting records for that specific product and batch. Cartridge processing documentation is separate from electronic handpiece documentation.
Quality Assurance
Quality review covers incoming materials, in-process checks, finished-product inspection, and traceability. Request the inspection information relevant to your selected product and project.
Contact TBPHP with the product model, destination market, and documentation needed for your sourcing review. Confirm the available documents and their scope before placing an order.