Everything You Need to Check Us Out
Three tiers, in the order a buyer actually uses them: registrations you can verify on a government website without asking us, documents you can open here, and reports we release per enquiry. Nothing here is gated behind a form you have to fill in first.
Selling on a marketplace, into pharmacies, or onto a retail chain? Jump to what your channel asks for ↓
Verify us yourself — no email required
These three records live on government registers we cannot edit. If what we tell you and what the register says ever disagree, the register wins — tell us and we correct our pages.
FDA cosmetic registration
FDA publishes no public database for cosmetic facility registrations, so this one cannot be checked online. We give you the FEI and send the submission confirmation on request.
Documents you can open now
Already published on this site, so there is nothing to request. Click to open, then save or print from your browser.
On request
Held by HLK, released per enquiry — we match each one to your market and SKU rather than sending a generic pack. One request covers as many of these as you need.
Testing reports
Each report names the laboratory and the standard. We send the version that matches your target market and SKU, and walk you through the method on a call.
- Skin irritation — ISO 10993-10 (SGS), adhesive film LOCTITE DURO-TAK 129A
- REACH SVHC — 250 substances screened at ≤ 0.1% (w/w)
- RoHS 2.0 (EU 2015/863) — restricted substances screening
- PFAS — EN 17681-1:2025, 675 substances screening
- VOC and free formaldehyde
- Magnetic nasal dilator CE technical documentation
Product and packaging
Specification sheets carry the dimensions, material build, adhesion grade and packing format we would actually run for your order.
- Specification sheet — nasal strips, mouth tape, face tape, sports tape
- Dieline templates for custom shapes and retail boxes
- Amazon FBA carton specification and FNSKU labelling layout
- Batch COA template
- OEM capability deck and current product catalogue
Shipping and commercial
Sent alongside a quotation, not as a standalone file — the numbers depend on volume, Incoterm and destination.
- Lead-time schedule by order size
- Incoterms and DDP landed-cost breakdown
- Sample kit contents and sampling fee credit terms
By sales channel: what you will be asked for
The list changes with the channel, not with the product. Each item is tagged with where to get it on this page — 01 verify 02 open 03 request with your order.
Amazon & online marketplaces
- CE declaration of conformity (EU listings)02
- UKCA declaration + UK Responsible Person (GB listings)02
- EU Authorised Representative details for the listing03
- Instructions for use in the destination language03
- FNSKU / barcode labels applied to units and cartonsorder
- Carton spec within the marketplace weight and size limits03
Marketplaces ask for these at listing review and again if a buyer complains. Having them ready before you list avoids takedowns during a launch.
Your own webshop & DTC
- Substantiation file for any wording on your product page03
- Skin-safety data — irritation and sensitisation03
- MSDS for carrier acceptance and returns handling02
- Country labelling — net quantity, responsible person, recycling marksorder
- Batch COA so you can answer a customer complaint with data03
Nobody checks these at the door, which is exactly why they catch people out later — usually when an ad platform or a regulator asks questions.
Pharmacy & drugstore
- CE marking, DoC and technical file02
- Manufacturer EUDAMED SRN01
- UDI-DI and Basic UDI03
- IFU / package leaflet in the national language03
- Batch COA per delivery03
Pharmacy buyers are the strictest channel we supply. They rarely accept a certificate alone — they want the leaflet and the UDI too.
Supermarket & retail chains
- GS1 / EAN barcodes — registered to your brandorder
- Retail-ready packaging and pallet plan03
- Master carton specification03
- REACH and PFAS declarations for the chain's chemical policy03
- Any social or quality audit the chain mandates03
Retail chemical policies are the part that surprises people: several European chains now screen for PFAS and SVHC well beyond what the law requires.
Medical distribution & tenders
- ISO 13485 quality-management certificate of the manufacturing chain03
- Full MDR technical file03
- UDI data set in the format the distributor uploads03
- Declaration of conformity per SKU02
- Tender dossier formatted to the buyer's template03
Tender paperwork is mostly formatting. We have the source documents; tell us the template and we fill it in.
This is what buyers have asked us to supply, not legal advice. Channel rules and marketplace policies change, and the final responsibility sits with the brand or importer placing the product on the market. Confirm your own obligations before you list — our EU certification guide is a starting point, and we will tell you plainly when something is outside what we can provide.
Resource questions
What buyers ask before they request anything.
Why are some documents behind a request instead of a download?
Can I check your registrations without contacting you?
Do you charge for documents or samples?
Which documents does an EU importer actually need?
I sell on Amazon, not through pharmacies. What do I actually need?
Is UKCA the same as CE?
More questions? Visit our full FAQ page or contact our team.
Start With the Registers, Not Our Sales Pitch
Check the MHRA and EUDAMED entries first. If they line up, send us your market, SKU and target volume — we will send back the documents that match.
