Reference · Compliance

Slow Duo Certification Pack

The document set a compliance team can file before the goods leave the port — listed item by item, with what each one proves and who issued it.

A wellness device that cannot clear customs is not a cheap purchase; it is a write-off with freight attached. Every certificate below is issued for the Slow Duo range as configured, and each is named to the specific standard it was tested against rather than to a generic "certified" claim.

Ships with every order — CE declaration of conformity — RoHS declaration — Per-batch QC report — Packing list and commercial invoice Ask for it before you book freight — REACH statement — Material test report by batch — UN38.3 for the cell — Third-party lab report on request The right-hand column is where delays come from: it exists, but it is not sent unless somebody asks.
Figure 1 The split that causes delays. The left column is sent automatically with a shipment; the right column exists and is released on request — which is why it is nearly always the right column that is missing when goods are held.
Documents issued with every Slow Duo shipment
DocumentWhat it establishesIssued or witnessed by
CE Declaration of ConformityConformity with the Low Voltage, EMC and RoHS directives for the EU marketManufacturer, held on technical file
RoHS conformity reportTen restricted substances measured by IEC 62321 methods, all below EU thresholdsSGS or Bureau Veritas
REACH statementPresence of SVHC candidates screened against the current candidate listSGS or Bureau Veritas
FDA material compliance statementSilicone composition measured against 21 CFR 177.2600 extractables limitsSGS
MSDS per skin-contact componentPrecise chemistry of every material that touches skinMaterial supplier, countersigned
Water-resistance batch reportIPX5, IPX6 or IP7 rating for that model, tested per IEC 60529Factory laboratory, per batch
Specification sheetDimensions, motor configuration, patterns, battery and charging figuresManufacturer
Commercial documentsInvoice, packing list, certificate of originManufacturer

Two things we will not do. We will not issue a certificate for a model we have not tested, and we will not present a material safety standard as a product approval. FDA 21 CFR 177.2600 governs rubber articles intended for repeated food contact; Slow Duo cites it because there is no FDA standard written specifically for this category, and the industry uses compliance with it as the reasonable material benchmark for the US. See the technology page for how that distinction is stated on the Product nodes.

  • Every certificate is traceable to a batch; a certificate without a batch reference is not evidence.
  • Third-party verification is available from SGS for materials and Bureau Veritas for the CE technical file.
  • Pre-shipment inspection can be booked directly with any third party at the factory address — there is no coordination fee and no required inspector.
  1. International Electrotechnical Commission (2013). Degrees of protection provided by enclosures (IP Code), IEC 60529, Edition 2.2. Geneva: IEC.
  2. European Parliament and Council (2023). Regulation (EU) 2023/988 on general product safety. Official Journal of the European Union.
  3. European Parliament and Council (2011). Directive 2011/65/EU on the restriction of hazardous substances in electrical and electronic equipment. Official Journal of the European Union.
  4. U.S. Food and Drug Administration (2024). 21 CFR 177.2600 — Rubber articles intended for repeated use. Code of Federal Regulations, Title 21.
EvidenceTest standards for every claimHow each figure on this page is measured.ReferenceMarket compliance matrixEU, UK, US, Canada, Australia side by side.AnswersCompliance questionsCertificates, verification and inspection.TermsWholesale termsMOQ, reorder minimum and lead times.GuideImport compliance for the EU, UK and USWhat each destination asks for at the border.ChecklistVet the supplier that issued themHow to tell a real report from a template.

Questions on this reference

Can I see the certificates before placing an order?

Yes. The certificate set is released to a verified buyer on request, and redacted versions are shared during due diligence. Nothing is withheld until purchase.

Who actually issued these reports?

Material and substance testing is carried out by SGS; CE technical-file review is available from Bureau Veritas. The factory issues its own per-batch water-resistance and function reports, which are the records that travel with your shipment.

Do the certificates name the model, or the range?

The model. A certificate issued for a product family is not evidence about the unit in your carton, so ask for the report that names the model and the batch you are buying. Compare it with the specification library.

How long does a certificate stay valid?

There is no universal expiry. A certificate is a statement about a configuration tested against an edition of a standard; when either the configuration or the edition changes, the statement has to be re-made. Read a two-year-old report as a question rather than as an answer.

Next: which of these documents each market inspects — or read the test behind each certificate.

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