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.
Which certificates ship with the order, and who issued each one?
The pack names the document, the issuing body and the scope for each item: CE covering LVD 2014/35/EU and EMC 2014/30/EU, RoHS reporting ten substances including four phthalates, an FDA material-safety statement for silicone per 21 CFR 177.2600, and an IPX5 test record per IEC 60529. UKCA is prepared on request. Every certificate number can be checked against the issuer's own registry, which is the verification step buyers most often skip. The wider reasoning sits in the compliance guide.
The split that causes delays
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.
The documents, item by item
| Document | What it establishes | Issued or witnessed by |
|---|---|---|
| CE Declaration of Conformity | Conformity with the Low Voltage, EMC and RoHS directives for the EU market | Manufacturer, held on technical file |
| RoHS conformity report | Ten restricted substances measured by IEC 62321 methods, all below EU thresholds | SGS or Bureau Veritas |
| REACH statement | Presence of SVHC candidates screened against the current candidate list | SGS or Bureau Veritas |
| FDA material compliance statement | Silicone composition measured against 21 CFR 177.2600 extractables limits | SGS |
| MSDS per skin-contact component | Precise chemistry of every material that touches skin | Material supplier, countersigned |
| Water-resistance batch report | IPX5, IPX6 or IP7 rating for that model, tested per IEC 60529 | Factory laboratory, per batch |
| Specification sheet | Dimensions, motor configuration, patterns, battery and charging figures | Manufacturer |
| Commercial documents | Invoice, packing list, certificate of origin | Manufacturer |
What we will not do
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.
How to check any certificate
The ingress records in this pack are issued against IEC 60529, which defines each IP level by its own test conditions rather than as a ladder of increasing protection — a fact that decides which claim a listing can make [International Electrotechnical Commission, 2013]. A pack is worth asking for precisely because the standards it names can be checked against the editions cited here.
According to the Wikipedia entry CE marking, the mark is the manufacturer's own declaration that the product meets the applicable directives, supported by a technical file that must be available to authorities; it is not a certificate issued to the manufacturer by a regulator. That distinction is the reason this page separates documents the manufacturer signs from reports a laboratory issues, a separation [Montgomery, 2013] would recognise as the difference between a specification and evidence that the specification was met.
References
- International Electrotechnical Commission (2013). Degrees of protection provided by enclosures (IP Code), IEC 60529, Edition 2.2. Geneva: IEC.
- European Parliament and Council (2023). Regulation (EU) 2023/988 on general product safety. Official Journal of the European Union.
- 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.
- U.S. Food and Drug Administration (2024). 21 CFR 177.2600 — Rubber articles intended for repeated use. Code of Federal Regulations, Title 21.
- Montgomery, D. C. (2013). Introduction to Statistical Quality Control (7th ed.). Hoboken: Wiley.
Questions on this reference
Are the RoHS and REACH report the same document?
No. A RoHS and REACH report covers two regimes with different purposes: RoHS restricts ten substances in electrical equipment, REACH screens for substances of very high concern in anything placed on the EU market. They are usually issued together by the same laboratory, which is why they are often mistaken for one certificate.
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.
A document set is only useful if you know which border will ask for which page. The import guide walks the three destinations in the order customs does, and the compliance matrix is the same information as a table. If your programme is private label rather than wholesale, the OEM terms state which documents change when the name on the label does. Where an order follows from this pack, it is formed under the B2B terms of trade, and the files exchanged on the way — briefs, artwork, redacted test packs — are held as described in the privacy notice.
Putting this reference to work
This page is the data. The four sections below are where it changes a decision: the terms it is quoted alongside, the guide that explains the reasoning, and the models the figures apply to.