Updated 22 October 2026
In-vitro diagnostics distributors in Austria: 23 licensed establishments
The Bastion Hale Distributor Index lists 23 establishments in Austria whose registry records include in-vitro diagnostics: 9 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 5 manufacturers' own import or sales entities, 0 regulatory representatives, and 9 manufacturers or exporters, out of 521 medical device establishments in Austria overall. The records come from EUDAMED, US FDA (openFDA), 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 | 13 | 57% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Authorised representative | 5 | 22% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 1 | 4% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 12 | 52% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 2 | 9% | 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 Austria
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 9 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 | Haemo Pharma GmbH Eisenstadt | Distributor Importer | Anaesthesia and respiratory, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +2 more | 0 | 0 | 11 | 19.2 | 4/5 |
| 2 | LabRaum Diagnostika GmbH Langenzersdorf | Distributor Importer | Anaesthesia and respiratory, Ear, nose and throat, Gastroenterology, urology and OB/GYN +2 more | 0 | 0 | 5 | 16.5 | 4/5 |
| 3 | HVD Life Science Vertriebs-GmbH Vienna | Distributor Importer | General hospital and consumables, In-vitro diagnostics, Patient monitoring and neurology +1 more | 0 | 0 | 3 | 15.0 | 4/5 |
| 4 | HVD Vertriebs-Gesellschaft m.b.H. Wien | Distributor Importer | General hospital and consumables, In-vitro diagnostics, Patient monitoring and neurology +1 more | 0 | 0 | 3 | 15.0 | 4/5 |
| 5 | Iaski Alzaga Alegre - PIA Diagnostika e.U. Fussach | Distributor Importer | In-vitro diagnostics | 0 | 0 | 2 | 13.9 | 4/5 |
| 6 | compliag GmbH Wien | Distributor Importer, Authorised representative | In-vitro diagnostics, Patient monitoring and neurology | 0 | 0 | 1 | 14.6 | 4/5 |
| 7 | CoaChrom Diagnostica GmbH Maria Enzersdorf | Distributor Importer, Authorised representative | In-vitro diagnostics, Patient monitoring and neurology | 0 | 0 | 0 | 11.9 | 3/5 |
| 8 | Josef Ruhri, Alpine Medical Devices Katzelsdorf | Distributor Importer, Authorised representative | Aesthetics, dermatology and lasers, In-vitro diagnostics, Surgery and endoscopy | 0 | 0 | 0 | 11.9 | 3/5 |
| 9 | Lab Technologies Medizintechnik GmbH Wien | Distributor Importer | In-vitro diagnostics | 0 | 0 | 0 | 9.7 | 3/5 |
Include manufacturers, their own sales entities and regulatory representatives (14)
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 | Greiner Bio-One GmbH 4550 | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | General hospital and consumables, In-vitro diagnostics, Surgery and endoscopy | 51 | 17 | 0 | 56.1 | 4/5 |
| 2 | Tecan Austria GmbH Groedig | Maker's own entity Authorised representative, Manufacturer | In-vitro diagnostics | 6 | 2 | 0 | 32.8 | 4/5 |
| 3 | Biegler GmbH Mauerbach | Maker's own entity Importer, Manufacturer | General hospital and consumables, In-vitro diagnostics | 5 | 2 | 0 | 32.0 | 4/5 |
| 4 | Axon Lab AG Polling | Maker's own entity Importer, Authorised representative | In-vitro diagnostics | 0 | 0 | 0 | 11.9 | 3/5 |
| 5 | Ascensia Diabetes Care Austria GmbH Vienna | Maker's own entity Importer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics, Patient monitoring and neurology | 0 | 0 | 0 | 9.7 | 3/5 |
| 6 | GREINER MEDISCAN GMBH KREMSMUNSTER Oberosterreich | Manufacturer Manufacturer | Cardiovascular, General hospital and consumables, Dental +3 more | 39 | 1 | 0 | 31.6 | 3/5 |
| 7 | GREINER MEDISCAN GMBH, STERILISATIONSANLAGE SEIBE SEIBERSDORF Niederosterreich | Manufacturer Manufacturer | General hospital and consumables, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +2 more | 16 | 1 | 0 | 27.3 | 3/5 |
| 8 | Takeda Manufacturing Austria AG VIENNA Wien | Manufacturer Manufacturer, Exporter | General hospital and consumables, In-vitro diagnostics | 4 | 1 | 0 | 23.4 | 3/5 |
| 9 | STRATEC Consumables GmbH Anif | Manufacturer Manufacturer | In-vitro diagnostics | 1 | 1 | 0 | 22.3 | 3/5 |
| 10 | TECHNOCLONE Vienna Wien | Manufacturer Manufacturer | In-vitro diagnostics | 3 | 1 | 0 | 20.0 | 3/5 |
| 11 | Novogenia GmbH Eugendorf | Manufacturer Manufacturer | In-vitro diagnostics | 1 | 1 | 0 | 19.8 | 4/5 |
| 12 | FLEXTRONICS INTERNATIONAL GMBH ALTHOFEN Karnten | Manufacturer Manufacturer | General hospital and consumables, In-vitro diagnostics | 2 | 1 | 0 | 18.5 | 3/5 |
| 13 | GESCHUETZTE WERKSTAETTEN INTEGRATIVE BETRIEBE SALZBURG GMBH St. Margareten Salzburg | Manufacturer Manufacturer | In-vitro diagnostics | 1 | 1 | 0 | 16.5 | 3/5 |
| 14 | PAYER International Technologies GMBH St. Bartholomae Steiermark | Manufacturer Manufacturer | In-vitro diagnostics | 1 | 1 | 0 | 16.5 | 3/5 |
Questions about in-vitro diagnostics distributors in Austria
How many in-vitro diagnostics distributors are there in Austria?
The Index counts 23 establishments in Austria with in-vitro diagnostics in their registry record, of which 9 are independent distributors (a channel role and no manufacturing of their own). The number comes from EUDAMED, US FDA (openFDA), MHRA UK and Health Canada and was last refreshed on 22 October 2026.
Who can hold a in-vitro diagnostics device registration in Austria?
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 Austria?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Austria 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 Austria?
A company that appears in a public regulatory registry with an address in Austria 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 Austria
In-vitro diagnostics in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 16 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 12 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 4 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 1 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- Company website (the establishment's own public site): 11 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.