Wholesale buyers should verify regulatory documents by exact model and destination market—not rely on a single “certified” badge. This guide explains the manufacturer documents reviewed by Justech for Dr.Pen microneedling products, what each document supports, and the claims it does not support.
Dr.Pen certification summary for buyers
| Document | Reference | What it supports | Important limitation |
|---|---|---|---|
| CE-LVD Certificate of Conformity | 00440KES5025S Issued 11 June 2024 | Electrical safety standards under Directive 2014/35/EU for the models printed in the certificate scope. | The certificate states that it is based on evaluation of one sample and does not constitute assessment of the entire production. |
| CE-EMC Certificate of Conformity | 00440KES5025E Issued 11 June 2024 | Electromagnetic compatibility standards under Directive 2014/30/EU for the listed model scope. | Scope is model-specific; it must not be extended to an unlisted model. |
| RoHS Certificate of Conformity | 00440KES5025R Issued 11 June 2024 | Testing standards cited for EU 2015/863 with 2011/65/EU for the listed model scope. | Buyers should confirm that the document and technical file meet the requirements of their destination market. |
| U.S. FDA 510(k) | K230420 Decision 11 August 2023 | The FDA database identifies the Dr. pen Microneedling System, applicant Guangzhou Ekai Electronic Technology Co., Ltd., product code QAI, with a Substantially Equivalent decision. | This is FDA 510(k) clearance—not “FDA approval”—and it does not automatically prove that every Dr.Pen model or intended use is covered. |
Which models are named in the CE and RoHS documents?
The supplied CE-LVD, CE-EMC and RoHS certificates explicitly name Dr. pen M8, M8S, A9, A11 and A20, as well as Needle Cartridge, MTS Needle and PMU Needle. They also name additional devices not discussed on this page. The supplied certificate lists reviewed by Justech do not name M9, so we do not apply those three certificate numbers to M9 without additional model-specific evidence.
What FDA K230420 means
The official FDA record for K230420 clearance letter classifies the Dr. pen Microneedling System as a Class II powered microneedle device under 21 CFR 878.4430. The decision is “Substantially Equivalent.” Accurate supplier wording is therefore “FDA 510(k) cleared under K230420” for the device scope in that record—not “FDA approved.”
FDA establishment registration and device listing are separate administrative requirements. Registration, listing or a third-party registration confirmation is not an FDA endorsement, and it must not be used to imply approval of all products.
How Justech handles certification requests
- We match the document to the exact model on the buyer’s quotation or proforma invoice.
- We confirm the destination country and intended commercial use before making a compliance statement.
- We provide the applicable document number and available copy for buyer due diligence before a bulk order.
- We separate manufacturer-level records from model-specific certificates.
- We recommend that importers confirm local registration, labeling and professional-use requirements with their compliance adviser.
Buyer verification checklist before ordering
| 1 | Confirm the exact model, cartridge type and intended use. |
|---|---|
| 2 | Ask for the current certificate or regulatory record and check whether the model is named. |
| 3 | Verify certificate number, issuer, issue date, standards and applicant/manufacturer name. |
| 4 | For U.S. claims, verify the FDA record directly and distinguish 510(k) clearance from registration. |
| 5 | Confirm destination-market labeling, importer and post-market obligations before shipment. |
Request the correct document set
Send Justech the model, quantity and destination country. We will identify the available model-specific documentation together with MOQ, tier pricing, packaging and lead time. Email: [email protected].
Compliance note: Regulatory requirements vary by country, intended use and sales channel. This page is a buyer-verification guide, not legal advice and not a representation that every Dr.Pen model is approved, cleared or registered in every market.
