CE-marked fillers for European distributors

CE-marked fillers and skin boosters for the European trade

Esthelix Global supplies European buyers with a deliberately narrow range: CE-marked hyaluronic-acid dermal fillers and skin boosters, together with the CE-marked poly-L-lactic acid line Sculptra. These are medical devices in Europe, and in the European Union dermal fillers fall under the Medical Device Regulation (EU) 2017/745 even when used for purely aesthetic purposes. We work only with ranges whose CE marking we have been able to confirm, such as Restylane and Restylane Skinboosters, Juvederm, Neuramis, e.p.t.q., Profhilo and NCTF 135HA.

Because the range is short, the conversation with each buyer can be specific: which lines, which references, how many units and what paperwork your import process needs.

Who can buy from us in Europe

European orders are accepted only from licensed businesses established in the destination market:

• Distributors that place medical devices on their national market and supply clinics and practitioners.
• Importers that bring devices into the EU, the UK or Switzerland under their own name and responsibility.
• Wholesalers that hold the trade registrations their country requires for medical-device distribution.

When a device enters the EU from a non-EU source, the business that receives it takes on the role of importer. Under Article 13 of the EU MDR, importers must check, among other things, that the device carries the CE marking, that a declaration of conformity exists, that the device has a UDI where required, and that labelling and instructions accompany it. Comparable duties apply in Great Britain under the UK Medical Devices Regulations 2002, and in Switzerland under the Swiss medical-device ordinance. We ask European buyers to confirm their status and to share their company details before we quote, and we decline orders where the buyer cannot take on those obligations.

We never sell to individuals, beauty salons without medical oversight or online consumer shops.

Your responsibilities as the importer

Before any unit is resold, the importer is responsible for verifying, for its own market:

• that the specific device reference is CE-marked and conforms to the applicable regulations;
• labelling and language requirements, including translated instructions where the national rules demand them;
• UDI and any national or EUDAMED registration duties;
• storage, traceability and vigilance arrangements.

Documents that originate with the manufacturer, such as the declaration of conformity or the instructions for use, are available from the manufacturer or its authorised representative. We can point you to the right reference, but we do not issue those documents ourselves.

How a European B2B order works

1. Send a list. Message +91 91801 57650 on WhatsApp with the products and quantities you need, together with your company name and country.
2. We check eligibility. Every line is checked against our CE list. Anything outside it is removed from the quote, with a note explaining why.
3. We confirm the quote. You receive US$ unit prices on the usual three tiers (1–4, 5–9 and 10+ units per product), the shipping cost to your address, the export documents confirmed for that order and a summary of the import steps that sit with you.
4. You approve and pay. Nothing is charged until you have accepted the full confirmed quote.
5. We ship. Goods leave in sealed original manufacturer packs, with the batch number and expiry date visible on every box.

Export documents

Export documents are confirmed per order before payment. Buyers typically ask for a commercial invoice, a packing list and origin-related shipping paperwork; tell us at the quote stage what your customs broker or regulatory team expects, and we will state clearly what can be provided for that consignment. Duties, VAT and clearance in the destination country remain the buyer's responsibility.

What we do not ship to Europe

The following product types are never shipped to the EU/EEA, the UK or Switzerland, whatever the order size:

• glutathione, vitamin, NAD+, collagen and placenta injectables;
• lipolytic and fat-dissolving injectables;
• neuromodulators;
• any filler, booster, thread or other product whose CE marking we cannot verify.

Separately, we do not ship to the United States or Canada at all.

If you are a licensed European distributor or importer looking for a second source of CE-marked fillers and skin boosters, send your list on WhatsApp and we will come back with a confirmed, line-by-line quote.