Updated 22 October 2026
Ophthalmic device distributors in Sweden: 11 licensed establishments
The Bastion Hale Distributor Index lists 11 establishments in Sweden whose registry records include ophthalmic: 2 with a channel role (importer, distributor, wholesaler or authorised representative), 0 registration holders without a channel role, and 9 registered as manufacturer or exporter only, out of 927 medical device establishments in Sweden overall. The records come from US FDA (openFDA), EUDAMED and Health Canada, last seen on 22 October 2026.
Ophthalmic covers intraocular lenses, diagnostic and surgical equipment, contact lenses and vision care. Buyers are eye hospitals, day surgery centres and optical retail, each with its own distributors. Intraocular lenses are a tender-driven, high-volume line in most public systems.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 1 | 9% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 2 | 18% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 1 | 9% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 7 | 64% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 6 | 55% | 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 Sweden
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 11 ophthalmic establishments by size
Channel roles first, then registration holders, then manufacturers. Size is a 0 to 100 score; Complete is 0 to 5.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | Mölnlycke Health Care AB Mölndal | Channel Importer, Distributor, Registration holder, Manufacturer | General hospital and consumables, Ophthalmic, Orthopaedics, spine and trauma +1 more | 62 | 52 | 0 | 60.3 | 3/5 |
| 2 | GLAS SCANDINAVIA AB Stockholm | Channel Distributor, Exporter | Ophthalmic | 3 | 1 | 0 | 22.2 | 3/5 |
| 3 | Stille AB Torshälla | Manufacturer Manufacturer | Cardiovascular, General hospital and consumables, Ear, nose and throat +6 more | 39 | 1 | 0 | 35.0 | 4/5 |
| 4 | Rini Ergoteknik AB Vallentuna | Manufacturer Manufacturer | Ophthalmic, Surgery and endoscopy | 3 | 1 | 0 | 23.4 | 4/5 |
| 5 | CHIMI AB Stockholm | Manufacturer Manufacturer, Exporter | Ophthalmic | 1 | 1 | 0 | 22.1 | 4/5 |
| 6 | OPAJE AB Stockholm | Manufacturer Manufacturer | Ophthalmic | 2 | 1 | 0 | 21.9 | 4/5 |
| 7 | AMO Uppsala AB Uppsala | Manufacturer Manufacturer | Ophthalmic | 1 | 1 | 0 | 19.8 | 4/5 |
| 8 | Acne Studios AB Spanga Stockholm | Manufacturer Manufacturer, Exporter | Ophthalmic | 1 | 1 | 0 | 18.7 | 3/5 |
| 9 | OSECO AB Orebro | Manufacturer Exporter | Ophthalmic | 2 | 1 | 0 | 18.5 | 3/5 |
| 10 | ANNA-KARIN KARLSSON EXCLUSIVE AB Stockholm Dalarna | Manufacturer Exporter | Ophthalmic | 1 | 1 | 0 | 16.5 | 3/5 |
| 11 | TOTEME AB Stockholm | Manufacturer Exporter | Ophthalmic | 1 | 1 | 0 | 16.5 | 3/5 |
Questions about ophthalmic distributors in Sweden
How many ophthalmic distributors are there in Sweden?
The Index counts 11 establishments in Sweden with ophthalmic in their registry record, of which 2 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA), EUDAMED and Health Canada and was last refreshed on 22 October 2026.
Who can hold a ophthalmic device registration in Sweden?
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 ophthalmic distributor in Sweden?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Sweden to reveal three profiles. For a shortlist with our read on each name, book the International Launch Audit.
What does the Distributor Index count as a ophthalmic distributor in Sweden?
A company that appears in a public regulatory registry with an address in Sweden and whose linked device listings fall in the ophthalmic segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in Sweden
Ophthalmic in other EU and EEA markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 11 establishments, last seen 22 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 6 establishments, last seen 22 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 1 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
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.