Buy Medical Equipment in Denmark

Danish labels for professionals too

In Denmark, labels and instructions for use must be in Danish whenever a device reaches its final user. The Danish Medicines Agency applies that to professional users as well. English is allowed only under a short-term exemption, which the maker or its authorised representative must apply for. Danish X-ray rules add a second gate, because installing a unit and acceptance testing it each require a permit from the Danish Health Authority.

We're MediGear, a company registered in England and Wales. As a distributor of medical devices, we quote certified equipment. Hospitals and clinics in more than 80 countries get their quotes, documents and freight from us. Send us the model or clinical need, and we find verified makers of health tech and medical equipment that can supply it with Danish labelling. Before the quote reaches your clinical engineers and purchasing staff, we work through the points on this page. Our buyers page takes requests, and no account is needed.

Regions, private hospitals and clinics

Until the end of 2026, there are five regions, each running one of the public Danish hospital systems. On 1 January 2027, Region Hovedstaden and Region Sjælland merge into Region Østdanmark, leaving four. Requests come from:

• Rigshospitalet and the other hospitals of the capital region
• The university hospitals in Aarhus and Odense, and Aalborg University Hospital with its sites in Aalborg, Farsø, Høro, Thisted and other towns
• Zealand University Hospital, whose first patients moved into its new hospital in Køge on 4 October 2026
• Private hospitals such as Aleris, which offers X-ray and scanning services at all its hospitals, and the Mølholm private hospital in Vejle
• Dental clinics and veterinary practices, where many units need only a notification to SST
• Municipalities buying devices for their own use, and FMI, which buys for the whole defence ministry group.
• Danish distributors registered with DKM.A

Public bodies that run healthcare in Denmark buy under the Danish Procurement Act. Amgros, owned by the regions, runs some device tenders with the regions' joint purchasing body, and large contracts are advertised in the EU's TED. For a dental clinic buying one intraoral unit, a clear written quote is enough to compare medical equipment companies.

DKMA, EUDAMED and the CVR test

The Danish Medicines Agency (DKMA) is the device authority, and devices need no approval from it before they are marketed. The Act on Medical Devices works with an executive order of December 2025, in force since 1 January 2026. Since 28 May 2026, makers, importers and authorised representatives have registered only in EUDAMED, while distributors established in Denmark register with DKMA. Only companies with a Danish CVR number register there. A foreign seller does not, but a Danish distributor buying from abroad does, and a Danish importer registers in EUDAMED.

Labelling and instructions must be in Danish when a device reaches its final user, and DKMA applies this to every user. Service manuals need not be translated in full, but safety-critical information must be in Danish. In a guide for municipalities, DKMA treats one that buys straight from a maker outside the EU for its own use as an end user, not an importer. Whether that view also covers a Danish hospital, or your own purchase, is a question for DKMA, as we are not an importer or distributor in Denmark and give no regulatory advice. Every quote does list the unit's certificates.

SST permits, notifications and registration

Radiation protection is the job of the Danish Health Authority (SST), through its radiation protection unit, under a radiation generator order in force since 1 January 2026. Firms that install, acceptance-test, inspect, or intervene in X-ray units need an SST permit. New users must notify SST or apply for an SST permit before use begins, as SST's page on radiation generators explains. Intraoral dental units other than handheld ones, OPG and cephalostat units and most veterinary units need only a notification for use. CT, fluoroscopy, interventional work and general X-ray need a use permit.

Every unit is registered with SST, and a notification or permit comes before use. The registration form asks for the room, shielding, serial number, and installer, with drawings and the acceptance test report attached; a move is also registered. Inspections then fall due at least every 13 months for permitted uses and every 25 months for notified ones. Status checks run every 13, 25 or 61 months, depending on the unit—a use permit lapses if the department changes its CVR number.

Type K sockets, stock reports and records

These points are agreed with the maker first:

• Socket types. The IEC lists type C, F and K plugs for Denmark, on a 230 V, 50 Hz supply. Check the socket on site, and raise any 110 V or 60 Hz design before the order.
• Testing. We found no Danish rule that sets a general testing cycle for devices outside radiation, so agree maintenance intervals with the maker.
• Stock levels. Since 1 January 2026, regions and municipalities can be told to report device use and stock, so list the spare parts and consumables a unit will need.
• Records. Agree DICOM and HL7 links with your health IT team early, so images and reports reach the right patient record.

Anything still open goes to the maker in writing before we quote, because the SST registration form needs the unit's serial number and test report.

DMS Import and the LFST wood rules

The importer first registers as one online and is given an EORI number made up of DK and its CVR number. Declarations go into DMS Import, the system of Toldstyrelsen, the Danish Customs Agency, lodged by the importer itself or by its forwarder or carrier. Our document pack for each order has:

• Commercial invoice and packing list for DMS Import
• Origin documents for the consignment
• HS codes for each line on the invoice
• Each model's declaration of conformity and CE certificate
• Danish labels and instructions for use

Wood packaging from outside the EU must be treated and marked under ISPM 15 as LFST, as set out by the agency for food, agriculture and fisheries for imports. Pre-notification in TRACES NT applies only to certain goods in wood packaging from India, China and Belarus, not the UK. Checks happen where goods first enter the EU, so we ask makers for heat-treated, stamped crates.

Which Danish port, and how to order

1. Name the unit. Send the model, quantity, and site via the RFQ form or email, and say who will install an X-ray unit.
2. Review the file. The quote, usually ready within 48 hours for catalogue items, lists certification, lead time, the Danish documents and the port.
3. Give the word. The maker hears from us once you have approved the quote by email or letter.
4. Sea and air. Sea freight into Aarhus, Fredericia or Copenhagen Malmö Port. For smaller items, ask whether air freight to an airport you name is possible.

Our delivery stops at the port or airport you nominate, where your forwarder lodges the import declaration in DMS Import, and the last leg is yours. If a hospital has several sites, name the one receiving the unit, such as Aalborg University Hospital, Farsø. For a hospital on Bornholm, mention it early, as the island is reached by sea or air.

Single units, new clinics and used X-ray

One patient monitor for a nursing unit, or one sensor for a dental clinic, can be ordered separately from standard catalogue lines. Multi-line requests for clinics are quoted too; see clinic setup for that work. Eye departments can browse ENT, Ophthalmic and Sensory, and hospital labs can send a list of laboratory equipment. Pre-owned units sit in our refurbished range, and our research turned up no Danish ban on them. DKMA treats a full refurbishment as a complete rebuild, and Danish labelling applies to refurbished medical equipment just as it does to new equipment. A used X-ray unit is registered, installed by a permit holder and acceptance-tested before clinical use.

Disclaimer

What you read here is general information for Danish buyers, not an offer to supply and not legal, regulatory or customs advice. We can quote only what makers can supply, and an order is firm once both sides have agreed it in writing. Devices need Danish labelling, and X-ray units need SST registration and a notification or permit before use. Clearing the goods and settling your regulatory position fall to you, as we are not a Danish importer or distributor.