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.
AEMPS registration & EU representative
The AEMPS entry is a notification record — not an approval and not a marketing authorisation, which its own document states. We send the filing on request.
ISO 9001 & ISO 13485
Both certificates are issued to HLK in its own name. The ISO 13485 scope covers the sale of semi-finished Class I devices — we will say so plainly if a tender asks for more.
EPR packaging registrations
Producer registrations under each country's packaging-waste law, not certificates — and the reason a listing gets blocked in Germany, France or Spain. The registers are national and mostly not searchable by outsiders, so we send the registration 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 10993-23:2021 (CTI / Guangdong Neway), the current standard
- Skin sensitisation (PONY Testing)
- Skin irritation — ISO 10993-10 (SGS), adhesive film LOCTITE DURO-TAK 129A, the report published above
- 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
Management system and registration
Certificates and filings held in HLK’s own name. We send the copy that matches the market and SKU on your order — not a generic scan.
- ISO 9001:2015 certificate — 98526Q00122R053, valid 6 August 2026 to 5 August 2029
- ISO 13485:2016 certificate — RZ7530335, scope: sales of Class I medical device semi-finished products
- EU Authorised Representative agreement — HUMISS TRADING S.L., Madrid (SRN ES-AR-000040177)
- Spain AEMPS registration filing — RPS/2201/2025
- Basic UDI-DI and UDI-DI data set — 697908092HLKMT1VT (mouth tape), 697908092HLKMT2VV (nasal strips)
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 how to order samples
Pick your channel, get the matching document package
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. Every card carries its own request button and its own WhatsApp message, already filled in with the list underneath it.
Amazon EU — DE / FR / ES / IT
Asked for at listing review, and again if a buyer complains.
- CE declaration of conformity 02
- EPR packaging registration for DE / FR / ES 01
- EU Authorised Representative — HUMISS TRADING S.L., Madrid (SRN ES-AR-000040177) 03
- Instructions for use in the marketplace language 03
- Amazon FBA carton specification 03
- FNSKU and barcode labels order
1 open now · 3 on request · 1 with your order · 1 verify yourself
Amazon UK
The same review as the EU, except CE is not accepted here — UKCA and a UK Responsible Person are.
- UKCA declaration (HLKNS1 / HLKMT1) 02
- UK Responsible Person — Intercert Global Ltd, London 03
- Instructions for use in English 03
- Amazon FBA carton specification 03
- FNSKU and barcode labels order
1 open now · 3 on request · 1 with your order
Amazon US
The cosmetic route under MoCRA — no CE here, but FDA registration and a US agent are asked for.
- FDA cosmetic facility registration, FEI 3041672188 01
- US agent — UNICO AMERICA CO., LTD. 03
- MSDS 02
- FBA carton specification and FNSKU labels 03
- English-language labelling order
1 open now · 2 on request · 1 with your order · 1 verify yourself
eBay, Allegro, Bol, Cdiscount
Lighter at listing, but national-language paperwork is still expected in DE and PL.
- CE or UKCA declaration by destination 02
- EPR packaging registration for DE / FR / ES 01
- Instructions for use in the national language 03
- REACH and PFAS declaration 03
- Substantiation file for your listing wording 03
- EAN barcode order
1 open now · 3 on request · 1 with your order · 1 verify yourself
Your own webshop and DTC
Nobody checks these at the door — which is why they surface later, when an ad platform or a regulator asks.
- Substantiation file for your page wording 03
- Skin-safety data — irritation and sensitisation 03
- MSDS 02
- Country labelling — net quantity, responsible person, recycling marks order
- Batch COA 03
1 open now · 3 on request · 1 with your order
Pharmacy and drugstore
The strictest channel we supply. A certificate on its own is rarely enough.
- CE marking, DoC and technical file 02
- Manufacturer EUDAMED SRN 01
- UDI-DI and Basic UDI (697908092HLKMT1VT / 697908092HLKMT2VV) 03
- IFU / package leaflet in the national language 03
- Batch COA per delivery 03
1 open now · 3 on request · 1 verify yourself
Supermarket and retail chains
Retail chemical policies now screen well past what the law requires.
- GS1 / EAN barcodes in your brand name order
- Retail-ready packaging and pallet plan 03
- Master carton specification 03
- REACH and PFAS declarations 03
- Social or quality audit the chain mandates 03
4 on request · 1 with your order
Medical distribution and tenders
Mostly formatting. We hold the source documents; you send the template.
- ISO 13485 certificate of the manufacturing chain 03
- Full MDR technical file 03
- UDI data set 03
- Declaration of conformity per SKU 02
- Tender dossier in the buyer template 03
1 open now · 4 on request
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.