Medical & Healthcare Supplies Manufacturers & Suppliers in Denmark

Smorum, Denmark

• Main activity as recorded in the state business register · Det Centrale Virksomhedsregister
• EU customs identifier (EORI) active · EU EORI validation

Ballerup, Denmark

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

Copenhagen, Denmark

Ballerup, Denmark

Bagsværd, Denmark

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

Aarhus, Denmark

Copenhagen, Denmark

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 21 medical devices: AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX (K163462, 2017-09-21), ABL800 FLEX with AQURE connectivity (K142898, 2015-06-17), Hematocrit and Metabolite QUALICHECK (K150226, 2015-05-13) +18. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Copenhagen K., Denmark

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

Copenhagen, Denmark

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

Roskilde, Denmark

• Registered as a manufacturer · ALIMS

Risskov, Denmark

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

Birkerød, Denmark

• Registered as a manufacturer · ALIMS

Assens, Denmark

• Registered as a manufacturer · ALIMS

Middelfart, Denmark

• Registered as a manufacturer · ALIMS

Smorum, Denmark

• Registered as a manufacturer · ALIMS

Ikast, Denmark

• Registered as a manufacturer · ALIMS

Lynge, Denmark

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 2 medical devices: WSA Self-Fitting Hearing Aid Gen 2 (K233464, 2024-02-09), Vibe SF Self-Fitting Hearing Aid (K220403, 2022-08-12). The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Denmark

• Listed as a distributor on a manufacturer's own site · Aerogen Ltd distributor list

Humlebaek, Denmark

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

Denmark

• Medicines manufacturing or import authorisation (MIA) · EudraGMDP manufacturing and importation authorisation register
• Registered with the U.S. FDA (active, renewed for the current year)

Ballerup, Denmark

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

Glostrup, Denmark

• Market access approved: European Union · TRACES NT
• Site address listed in a government regulator's register · European Industrial Emissions Portal

Denmark

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 2 medical devices: LYNX Photocoagulator (K242397, 2024-10-25), Leaf Photocoagulator (K190083, 2019-05-03). The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Denmark

• Medicines manufacturing or import authorisation (MIA) · EudraGMDP manufacturing and importation authorisation register

Svendborg Syddanmark, Denmark

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

Vedbaek Hovedstaden, Denmark

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

ROEDBY Sjalland, Denmark

• Site address listed in a government regulator's register · US FDA device establishment registration
• Registered with the U.S. FDA (active, renewed for the current year)

Espergaerde Hovedstaden, Denmark

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

Soeborg Hovedstaden, Denmark

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

BALLERUP Hovedstaden, Denmark

• Registered with the U.S. FDA as a Contract Manufacturer
• Places goods on the market (national producer register) · Registre national des producteurs

Roedding Syddanmark, Denmark

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

Birkeroed Hovedstaden, Denmark

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

Middelfart Syddanmark, Denmark

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 8 medical devices: Orion (K200529, 2020-08-12), VisualEyes (K200534, 2020-08-12), TRV (K192652, 2020-05-27) +5. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Frederiksvaerk Hovedstaden, Denmark

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

Struer, Denmark

• Registered as a manufacturer · ALIMS

Jyderup Sjalland, Denmark

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

STRUER Midtjylland, Denmark

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

FARUM Hovedstaden, Denmark

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 18 medical devices: MagVenture Accelerated TMS (aTMS) Therapy System (K260189, 2026-05-22), MagVenture TMS Therapy System (K251125, 2025-08-11), MagVenture TMS Therapy System (K251119, 2025-08-08) +15. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

IKAST Midtjylland, Denmark

• Site address listed in a government regulator's register · US FDA device establishment registration
• Registered with the U.S. FDA (active, renewed for the current year)

Viby J Midtjylland, Denmark

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 4 medical devices: EmbryoSlide+ ic8 dish (K213869, 2022-03-11), KIDScore D3 (K182798, 2019-07-19), EmbryoScope+ (K173264, 2018-05-11) +1. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Aabenraa, Denmark

• Site address listed in a government regulator's register · Fødevarestyrelsen

Denmark

Goerloese Hovedstaden, Denmark

• Applicant to the US FDA for 7 medical devices: Elos Accurate® Denture Fixation System (K253774, 2026-05-20), Elos Accurate Hybrid Base (K251497, 2025-10-16), Elos Accurate® Hybrid Base™ (K242025, 2024-12-10) +4. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510
• Site address listed in a government regulator's register · US FDA device establishment registration

Taastrup Hovedstaden, Denmark

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