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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.

GREAT BRITAIN

MHRA registration & UKCA

  • MHRA reference38014
  • Device typesGMDN 66302 & 67430
  • DeclarationsHLKNS1 · HLKMT1
  • UK Responsible PersonIntercert Global Ltd, London
EUROPEAN UNION

EUDAMED & CE MDR

  • Manufacturer SRNCN-MF-000049679
  • Registered24 Sep 2025
  • FrameworkEU MDR 2017/745, Class I
  • CoversNasal strips & mouth tape
UNITED STATES

FDA cosmetic registration

  • RegistrationFacility, MoCRA
  • FEI number3041672188
  • Effective13 May 2026
  • US agentUNICO AMERICA CO., LTD.

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.

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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
Need any of it? Tell us your market and SKU. We reply within one working day with the matching files.

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?
Two reasons. Testing reports carry laboratory report numbers we keep out of public circulation, so we release them per enquiry and match them to the market and SKU you are actually buying. Specification sheets and dielines depend on your chosen material, shape and packing format — a generic version would be wrong for you. Everything in the "open now" tier is already public on this site and needs no gate.
Can I check your registrations without contacting you?
Yes, and you should. Our MHRA entry is public on the government register (reference 38014) and our EUDAMED record is public as manufacturer SRN CN-MF-000049679 — both are linked above and neither is hosted or editable by us. The US is the exception: FDA does not publish a public database for cosmetic facility registrations under MoCRA, so there we give you our FEI number (3041672188) and send the submission confirmation on request.
Do you charge for documents or samples?
Documents are free. Samples carry a sampling fee that is credited back against your first production order; sample quantities start from 10 pcs, while production runs start from 500 boxes for stock specifications and 5,000 boxes for custom packaging.
Which documents does an EU importer actually need?
At minimum: the CE declaration of conformity with its technical file, an EU Responsible Person where applicable, MSDS for the adhesive and materials, and a batch COA. If you sell in Great Britain you need the UKCA declaration and a UK Responsible Person on top. Our <a href="/guide/eu-nasal-strip-certifications/">EU certification guide</a> walks through each one, and <a href="/guide/verify-nasal-strip-factory/">how to verify a factory</a> covers what to ask a supplier before you pay.
I sell on Amazon, not through pharmacies. What do I actually need?
For an EU listing you need the CE declaration of conformity, an EU Authorised Representative named on the listing, and instructions for use in the marketplace language; for Great Britain you need the UKCA declaration and a UK Responsible Person. Beyond compliance, Amazon will reject cartons that break its weight and size limits and units without a scannable FNSKU, so those two are practical blockers rather than legal ones. See <a href="#channels">the channel list</a> for the full set, or our <a href="/blog/amazon-fba-private-label-nasal-strips-guide/">Amazon FBA guide</a> for the packaging side.
Is UKCA the same as CE?
No. UKCA applies in Great Britain (England, Scotland and Wales) and CE applies in the EU; Northern Ireland follows its own arrangement. Our UKCA declarations are issued per SKU — model HLKNS1 for nasal strips and HLKMT1 for mouth tape — not per company, and Class I devices have no notified body and no certificate, only the manufacturer’s declaration.

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.

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