Updated 22 October 2026
In-vitro diagnostics distributors in Denmark: 30 licensed establishments
The Bastion Hale Distributor Index lists 30 establishments in Denmark whose registry records include in-vitro diagnostics: 3 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 8 manufacturers' own import or sales entities, 0 regulatory representatives, and 19 manufacturers or exporters, out of 620 medical device establishments in Denmark overall. The records come from US FDA (openFDA), EUDAMED, MHRA UK and Health Canada, last seen on 23 October 2026.
In-vitro diagnostics covers analysers, reagents, rapid tests and laboratory consumables across chemistry, haematology, microbiology, immunology and genetics. IVD has its own regulation in most markets, and the EU regulates it under IVDR rather than MDR. Laboratory distributors usually differ from device distributors, even inside the same company.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 10 | 33% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 2 | 7% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 3 | 10% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 5 | 17% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 23 | 77% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 4 | 13% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in Denmark
In the EU and EEA the manufacturer, or its EU authorised representative for manufacturers based outside the EU, registers in EUDAMED and holds the CE marking file. Importers and distributors register separately as economic operators and never own the registration, which is why EU channel changes are easier than elsewhere.
Top 3 independent in-vitro diagnostics distributors
Independent distributors only, ranked by the other manufacturers' lines they carry, then registrations held, then size.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | Intramedic A/S Nærum | Distributor Importer | Cardiovascular, In-vitro diagnostics, Patient monitoring and neurology | 0 | 0 | 16 | 20.5 | 4/5 |
| 2 | MEDshop.dk ODENSE NV | Distributor Importer | Cardiovascular, Ear, nose and throat, In-vitro diagnostics +1 more | 0 | 0 | 4 | 15.8 | 4/5 |
| 3 | Nordic Tests ApS København N | Distributor Importer | In-vitro diagnostics | 0 | 0 | 0 | 9.7 | 3/5 |
Include manufacturers, their own sales entities and regulatory representatives (27)
Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | Ambu A/S Ballerup | Maker's own entity Importer, Distributor, Authorised representative, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +6 more | 84 | 44 | 0 | 63.9 | 4/5 |
| 2 | SSI Diagnostica A/S Hillerød | Maker's own entity Importer, Registration holder, Manufacturer | In-vitro diagnostics | 11 | 7 | 0 | 43.6 | 4/5 |
| 3 | Agilent Technologies Denmark ApS Glostrup | Maker's own entity Importer, Distributor, Authorised representative, Manufacturer, Exporter | General hospital and consumables, In-vitro diagnostics | 50 | 1 | 0 | 42.4 | 4/5 |
| 4 | Vitrex Medical A/S Herlev | Maker's own entity Importer, Manufacturer | In-vitro diagnostics | 2 | 1 | 0 | 26.6 | 4/5 |
| 5 | NUNC A/S Roskilde | Maker's own entity Authorised representative, Manufacturer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 2 | 1 | 0 | 24.2 | 3/5 |
| 6 | Argon Medical Devices Danmark ApS Ballerup | Maker's own entity Importer | Cardiovascular, General hospital and consumables, Ear, nose and throat +5 more | 0 | 0 | 0 | 9.7 | 3/5 |
| 7 | Ascensia Diabetes Care Denmark ApS Kastrup | Maker's own entity Importer | In-vitro diagnostics, Patient monitoring and neurology | 0 | 0 | 0 | 9.7 | 3/5 |
| 8 | MEDISTIM DANMARK ApS Ringsted | Maker's own entity Importer | Cardiovascular, Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 0 | 0 | 0 | 9.7 | 3/5 |
| 9 | Radiometer Medical ApS Brønshøj | Manufacturer Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +3 more | 134 | 44 | 0 | 62.4 | 4/5 |
| 10 | BioPorto Diagnostics A/S Hellerup | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics | 6 | 3 | 0 | 34.1 | 4/5 |
| 11 | AMS Denmark ApS Hundested | Manufacturer Registration holder, Manufacturer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 5 | 3 | 0 | 33.3 | 4/5 |
| 12 | Sterigenics Denmark A/S Espergaerde Sjaelland | Manufacturer Manufacturer | Cardiovascular, General hospital and consumables, Dental +6 more | 50 | 1 | 0 | 32.9 | 3/5 |
| 13 | ATSI Logistics Center ApS GLOSTRUP Hovedstaden | Manufacturer Exporter | General hospital and consumables, In-vitro diagnostics | 46 | 1 | 0 | 32.4 | 3/5 |
| 14 | GP Medical Devices A/S Holstebro | Manufacturer Manufacturer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 3 | 1 | 0 | 25.8 | 4/5 |
| 15 | MEQU A/S Copenhagen | Manufacturer Manufacturer | General hospital and consumables, In-vitro diagnostics | 2 | 1 | 0 | 24.3 | 4/5 |
| 16 | MotilityCount ApS Valby | Manufacturer Manufacturer, Exporter | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 2 | 1 | 0 | 24.2 | 3/5 |
| 17 | CODAN MEDICAL APS. ROEDBY Sjaelland | Manufacturer Manufacturer | General hospital and consumables, In-vitro diagnostics, Ophthalmic +1 more | 7 | 1 | 0 | 23.5 | 3/5 |
| 18 | PAUL E. DANCHELL A/S Jyderup Sjaelland | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +2 more | 7 | 1 | 0 | 23.5 | 3/5 |
| 19 | Immudex, Aps Virum | Manufacturer Manufacturer | In-vitro diagnostics | 3 | 1 | 0 | 23.4 | 3/5 |
| 20 | BiopSafe ApS Vedbaek | Manufacturer Manufacturer | In-vitro diagnostics | 1 | 1 | 0 | 22.3 | 4/5 |
Questions about in-vitro diagnostics distributors in Denmark
How many in-vitro diagnostics distributors are there in Denmark?
The Index counts 30 establishments in Denmark with in-vitro diagnostics in their registry record, of which 3 are independent distributors (a channel role and no manufacturing of their own). The number comes from US FDA (openFDA), EUDAMED, MHRA UK and Health Canada and was last refreshed on 22 October 2026.
Who can hold a in-vitro diagnostics device registration in Denmark?
In the EU and EEA the manufacturer, or its EU authorised representative for manufacturers based outside the EU, registers in EUDAMED and holds the CE marking file. Importers and distributors register separately as economic operators and never own the registration, which is why EU channel changes are easier than elsewhere.
How do I find a in-vitro diagnostics distributor in Denmark?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Denmark to reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a in-vitro diagnostics distributor in Denmark?
A company that appears in a public regulatory registry with an address in Denmark and whose linked device listings fall in the in-vitro diagnostics segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in Denmark
In-vitro diagnostics in other EU and EEA markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 24 establishments, last seen 23 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 22 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- UK MHRA Public Access Registration Database (PARD): 8 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 5 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- Company website (the establishment's own public site): 6 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.
Index build 22 October 2026. Each establishment is counted once per country after resolving names across sources. Named individuals are never collected.
Registry data. Bastion Hale does not vouch for any establishment.