Documents by market
Every order ships with a commercial invoice, a packing list and the transport document. Test reports and declarations are requested for the exact product, and those agreed are named on your quotation, and the registered designs of two adjustable mouthpieces are shown below.
Plan documents for this reference
Choose the reference and the market you plan to sell in.
Document holders and scope
Ask the maker, seller, brand owner or laboratory to name the responsible document holder. Agree whose name goes on a report before a test is booked.
For each requested document for the exact product and market, confirm availability, scope, holder, permission to share or rely on it, and any cost before relying on it.
Confirm which documents apply to your exact product and which business holds each before ordering.
Select a reference and market to see its document requests.
Document requests by reference and market:
XMD-SNR-011 — United States
Options: Clear
In the box: Mouthpiece, vented storage case, insert card
Requirements vary by product, claims, market and supply-chain role. A registration or device listing identifies the business and reported devices; it is not an approval or clearance.
Request the documents relevant to your exact product and market before ordering.
- Material declaration
Ask the maker. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- Biocompatibility tests on the finished material
Ask the laboratory. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- Extractables or a food-contact-style declaration for EVA
Ask the laboratory. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- Statement on restricted substances
Ask the maker. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- device clearance
Ask the maker. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- establishment registration
Ask the maker. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- device listing
Ask the seller. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
XMD-NGD-010 — European Union
Options: Large or small single; two-and-two or four-and-four sets in a colour box
In the box: Tray; colour box on the set options
Requirements vary by product, claims, market and supply-chain role. A registration or device listing identifies the business and reported devices; it is not an approval or clearance.
Request the documents relevant to your exact product and market before ordering.
- Material declaration
Ask the maker. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- Biocompatibility tests on the finished material
Ask the laboratory. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- Extractables or a food-contact-style declaration for EVA
Ask the laboratory. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- Lead, phthalate and heavy-metal reports
Ask the laboratory. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- Statement on restricted substances
Ask the maker. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- technical file
Ask the maker. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- notified-body certificate where the class needs one
Ask the brand owner. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
XMD-WHT-003 — European Union
Options: Pink, white or silver pens
In the box: LED tray light, cable, three pens, insert card, colour box
Requirements vary by product, claims, market and supply-chain role. A registration or device listing identifies the business and reported devices; it is not an approval or clearance.
Request the documents relevant to your exact product and market before ordering.
- Material declaration
Ask the maker. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- Biocompatibility tests on the finished material
Ask the laboratory. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- Ingredient list and certificate of analysis
Ask the maker. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- Electromagnetic and restricted-substances reports
Ask the laboratory. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- Statement on restricted substances
Ask the maker. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- product information file
Ask the brand owner. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- safety report
Ask the brand owner. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- notification before sale
Ask the brand owner. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- declaration of conformity for the light
Ask the maker. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
XMD-WHT-001 — European Union
Options: Light with the adapter cable
In the box: LED tray light, three-way adapter cable
Requirements vary by product, claims, market and supply-chain role. A registration or device listing identifies the business and reported devices; it is not an approval or clearance.
Request the documents relevant to your exact product and market before ordering.
- Material declaration
Ask the maker. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- Biocompatibility tests on the finished material
Ask the laboratory. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- Electromagnetic and restricted-substances reports
Ask the laboratory. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- Statement on restricted substances
Ask the maker. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
- declaration of conformity for the light
Ask the maker. Buyer action: request with quotation. Confirm its availability, scope and holder on the quotation.
XMD-SNR-018 — United States
Options: Blue trays; clear-blue trays with fitting tool; clasp night guard in white or clear
In the box: Mouthpiece, storage case, insert card, colour box; the clasp guard with its case
Requirements vary by product, claims, market and supply-chain role. A registration or device listing identifies the business and reported devices; it is not an approval or clearance.
Choose the exact product option before requesting market documents.
With every order
- Commercial invoice, naming the seller of record your proforma named.
- Packing list, with pieces per carton and carton weights.
- The transport document for the mode you chose.
- A manufacturer invoice in the form marketplaces ask for, on request.
Test reports and declarations
| Document | For | What it supports |
|---|---|---|
| Material declaration | every reference | Names the polymer and the colourant; the first document a retailer asks for |
| Biocompatibility tests on the finished material | trays, frames, guards | Ask a qualified assessor to set the assessment scope for the final finished article and processing; this label does not specify a complete test package |
| Extractables or a food-contact-style declaration for EVA | EVA trays | Retail onboarding in Europe and North America |
| Lead, phthalate and heavy-metal reports | youth guards, cases | Confirm the applicable product rules and retailer requirements before setting the test scope; a youth label alone does not decide them |
| Ingredient list and certificate of analysis | gels and pens | Records the ingredients, percentage and pH for the quoted formulation. The buyer and adviser confirm the requirements for the intended market. |
| Electromagnetic and restricted-substances reports | the LED light | The electronics file in the EU and UK; an emissions report for the United States |
| Skin irritation and sensitisation report | mouth tape | The skin-contact data behind a tape listing |
| Statement on restricted substances | every reference | The yes-or-no question on a retailer's onboarding form, with the paper behind it |
Whose name goes on a report is agreed before the test is booked. A report in your name is yours to hand to a marketplace or a regulator; a shared report becomes another brand's document.
Registered designs
Two adjustable anti-snoring mouthpiece designs are registered. The push-adjust mouthpiece with the graduated slide holds an EU registered Community design and a UK registered design (registered in January and February 2024) and a Chinese design patent (granted in October 2024); the sixth-generation adjustable mouthpiece holds an EU registered Community design and a UK registered design (December 2024). The certificates below are shown with their numbers, holder details and codes masked and a watermark over each page; the originals are shown to buyers with a quotation, on request. Select a certificate to open its full-size masked copy. A registered design protects the shape of the product in that market; it is not a safety or performance document.
Regulatory documents and responsibilities by market
Each market sets its own regulatory documents and duties. The table names what to settle with your adviser for each product family.
| Market | Mouthpieces and night guards | Whitening gels | Light, sports guards and tape |
|---|---|---|---|
| United States | Any applicable device clearance, and each business's establishment registration and device listing duties by its actual activities. | Cosmetic facility registration, product listing, exemptions and any US-agent requirement. | For youth guards, whether CPSC children's-product safety rules apply, then testing and certification; the light's applicable emissions requirements. |
| European Union | Classification and conformity route, technical file, and the authorised-representative and importer roles applicable to the supply chain. | For a cosmetic, the responsible person, product information file, safety report and notification before sale. | The applicable product-safety or protective-equipment route and any responsible-person or assessment requirements, including a declaration of conformity for the light where applicable. |
| Great Britain | The exact device under GB rules: the applicable marking route, MHRA registration and whether a UK Responsible Person is required. | For a cosmetic, a UK-established Responsible Person, safety file and SCPN notification. | The exact light, sports guard or tape under GB rules. |
| Northern Ireland | The exact device under EU rules: CE conformity, any EU or Northern Ireland authorised representative, and current registration requirements. UKCA is not accepted here. | For a cosmetic, an EU or Northern Ireland Responsible Person, safety file and CPNP notification. | The exact light, sports guard or tape under the rules applicable in Northern Ireland. |
| Canada | The product class and any establishment or device licence required for the actual importer or distributor. | Cosmetic notification, formulation limits and supporting data for the exact gel. | Applicable consumer-product or other duties for the exact product. |
| Australia | Whether register inclusion is required and which business acts as sponsor. | Poisons-schedule labelling and industrial-chemicals obligations for the exact formulation. | Applicable consumer-product or other duties for the exact product. |
The compliance by market guide sets out the classes and the roles in more detail. Great Britain (England, Scotland and Wales) and Northern Ireland need separate assessments. A registration or a device listing identifies the business and the devices it reports; neither is an approval or clearance.
Documents on your quotation
Your quotation names every document that will travel with the order and every report arranged for it, with the holder's name and the laboratory. A document that is not on the quotation is not part of the order. Ask for the list before you place the order, and send your marketplace's or your retailer's onboarding form, so the list is built against it.
Your message opens in WhatsApp with the page name added, so the desk knows what you are looking at.
Or write to sales@xinmeidaoralcare.com.
Notes
Test reports and declarations. Request each document for the exact product, and confirm its availability, scope, holder, permission to share or rely on it, and any cost before relying on it.
Regulatory documents. These are identified for the exact product and business roles; the desk does not supply a market clearance with an order. Before ordering, agree which business holds each required document, which documents apply to your exact product, and which responsibilities remain with you.
Sources. The GB/NI distinctions and US role questions were checked against the primary sources linked in the compliance guide on 8 September 2026. This guide is not legal advice.