Medical & Healthcare Supplies Manufacturers & Suppliers in Sweden

Malmö, Sweden

• Registry ID checks out with the state register · GLEIF Global LEI record

Stockholm, Sweden

• Registered as a manufacturer · ALIMS
• Registered with the U.S. FDA (active, renewed for the current year)

Angelholm, Sweden

• Applicant to the US FDA for 2 medical devices: HemoCue Hb 301 System (K201217, 2020-08-04), HemoCue Hb 801 System (K181751, 2019-02-01). The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510
• Registered with the U.S. FDA (active, renewed for the current year)

Gothenburg, Sweden

• Registered as a manufacturer · ALIMS
• Registered with the U.S. FDA (active, renewed for the current year)

Torekov, Sweden

Lulea, Sweden

• Registered as a manufacturer · ALIMS

Vaxjo, Sweden

• Registered as a manufacturer · ALIMS

Stockholm, Sweden

• Registered as a manufacturer · ALIMS
• Site address listed in a government regulator's register · US FDA device establishment registration

Uppsala, Sweden

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 2 medical devices: CoroFlow Cardiovascular System (K252238, 2025-10-24), CoroFlow Cardiovascular System (K201881, 2020-11-13). The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Lund, Sweden

• Registered as a manufacturer · ALIMS

Danderyd, Sweden

• Registered as a manufacturer · ALIMS

Uppsala, Sweden

• Registered as a manufacturer · ALIMS

Stockholm, Sweden

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 17 medical devices: Affinity (K253835, 2026-07-31), Hybrid Viewer (00859873006240) (K252477, 2025-09-09), Voxel Dosimetry (00859873006226) (K243919, 2025-07-30) +14. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Goteborg, Sweden

• Registered as a manufacturer · ALIMS

Umea, Sweden

• Registered as a manufacturer · ALIMS
• Market access approved: European Union · TRACES NT

Täby, Sweden

• Registered as a manufacturer · ALIMS

Linkoping, Sweden

• Registered as a manufacturer · ALIMS

Hollviken, Sweden

• Registered as a manufacturer · ALIMS
• Registered with the U.S. FDA (active, renewed for the current year)

Gothenburg, Sweden

• Registered with the U.S. FDA (active, renewed for the current year)

Uppsala, Sweden

Stockholm (Estocolmo), Sweden

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 15 medical devices: Leksell® Vantage Stereotactic System (K261932, 2026-08-05), Monaco RTP System (6.3) (K252002, 2026-02-19), EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) (K252188, 2026-01-15) +12. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Malmö, Sweden

• Medicines manufacturing or import authorisation (MIA) · EudraGMDP manufacturing and importation authorisation register
• Site address listed in a government regulator's register · European Industrial Emissions Portal

Stockholm (Estocolmo), Sweden

• Places goods on the market (national producer register) · Registre national des producteurs
• Registered with the U.S. FDA (active, renewed for the current year)

Sweden

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 8 medical devices: ProTrach Dualcare (K151404, 2016-02-12), PROVOX FREEHANDS FLEXIVOICE (K141380, 2014-09-26), PROVOX VEGA PUNCTURE SET (K131947, 2013-10-18) +5. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Sweden

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 13 medical devices: EveryWare (K242485, 2025-05-20), Clearo (K242438, 2025-05-16), Vivo 45 LS (K233452, 2025-01-13) +10. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Uppsala, Sweden

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 2 medical devices: TIGR Matrix Surgical Mesh, TIGR Surgical Mesh (K191749, 2020-03-26), TIGR Matrix Surgical Mesh (K163005, 2017-07-27). The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Perstorp, Sweden

• Registered with the U.S. FDA (active, renewed for the current year)

Sweden

• Registered as a manufacturer · ALIMS
• Registered with the U.S. FDA (active, renewed for the current year)

MOLNLYCKE Vastra Gotaland, Sweden

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

Kisa Ostergotland, Sweden

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

Broakulla Kalmar, Sweden

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

Umea Vasterbotten, Sweden

• Registered with the U.S. FDA as a Contract Manufacturer
• Market access approved: European Union · TRACES NT

VAXJO Kronoberg, Sweden

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

Tyresoe Stockholm, Sweden

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

Helsingborg Skane, Sweden

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

KOPPARBERG Orebro, Sweden

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

SOLNA Stockholm, Sweden

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

Smalandsstenar Jonkoping, Sweden

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

Skara Vastra Gotaland, Sweden

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

Lysekil Vastra Gotaland, Sweden

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

Tyreso, Sweden

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

Harnosand Vasternorrland, Sweden

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

Malmo Skane, Sweden

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

Stockholm, Sweden

Stockholm, Sweden

Norrtälje, Sweden

• Registry ID checks out with the state register · GLEIF Global LEI record

MJOLBY Ostergotland, Sweden

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

TIMMERSDALA Vastra Gotaland, Sweden

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration