Updated 23 October 2026
Medical device distributors in North Macedonia: 2 licensed establishments
North Macedonia has 2 licensed establishments in the Index and no independent distributor yet.
The Bastion Hale Distributor Index lists 2 medical device establishments registered with an address in North Macedonia: 0 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 0 manufacturers' own import or sales entities, 0 regulatory representatives (authorised representatives or registration holders with no import or distribution role), and 2 manufacturers or exporters. The records come from US FDA (openFDA), last seen on 22 October 2026.
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Include manufacturers, their own sales entities and regulatory representatives (2)
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.
- 1BRAKO D.O.OVeles0 lines1 registrationsize 22.8
- 2Amphenol Technology Macedonia Bernd RichterKochani Kocani0 lines1 registrationsize 18.5
By segment
| Segment | Establishments | |
|---|---|---|
| Cardiovascular | 1 | Find distributors for your device |
| Patient monitoring and neurology | 1 | Find distributors for your device |
| General hospital and consumables | 1 | Find distributors for your device |
Segments come from the device listings linked to each establishment, so one company can appear in several rows. Imaging and radiology are shown because the registries contain them.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Manufacturer | 2 | 100% | Registered as a manufacturer with an address in this market, including foreign registrations. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in North Macedonia
Who holds the registration varies by market and often sits with the local importer. Check the national rule before signing a distributor.
This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later. The Next 10 Markets report covers who holds the registration in each of your ten markets.
Questions about medical device distributors in North Macedonia
How many medical device distributors are there in North Macedonia?
The Index counts 2 medical device establishments registered in North Macedonia, of which 0 are independent distributors: importers, distributors, wholesalers or authorised representatives that do not manufacture themselves and are not a manufacturer's own sales company. The rest are manufacturers or their own sales entities. The number comes from US FDA (openFDA) and was last refreshed on 23 October 2026.
Who can hold a medical device registration in North Macedonia?
Who holds the registration varies by market and often sits with the local importer. Check the national rule before signing a distributor.
How do I find a medical device distributor in North Macedonia?
Start with the segment table on this page, open the top establishments and check their roles, principals and registration counts. Then search the Index for your device and North Macedonia to see the counts for your segment and see the top three names. For a ranked shortlist for your device, see the Next 10 Markets report.
What does the Distributor Index count as a distributor in North Macedonia?
An establishment is a company that appears in a public regulatory registry with an address in North Macedonia, in any of the roles importer, distributor, wholesaler, authorised representative, sponsor, registration holder, manufacturer or exporter. Each company is counted once per country even if it holds several licences or appears in several registries. No contact people are collected.
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Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 2 establishments, last seen 22 October 2026. US government work, public domain.
Index build 23 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.
Registry data. Bastion Hale does not vouch for any establishment.