Medical device makers in Denmark: 99 FDA-registered establishments

Name: FDA-registered medical device makers in Denmark
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

99 establishments in Denmark are registered with the FDA to make medical devices for the US market, listing 330 device types. 49 have a 510(k) clearance or PMA approval on file and 13 have a recall event. FDA data exported November 2, 2026.

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DenmarkCountry

Device types made here

Device types with the most registered makers in this country.

Device	Product code	Makers
Frame, Spectacle	HQZ	6
Aid, Transfer	IKX	5
Audiometer	EWO	4
Labware, Assisted Reproduction	MQK	4
Hearing Aid, Air-Conduction, Prescription	ESD	4
Sunglasses (Non-Prescription Including Photosensitive)	HQY	4
Chair, Adjustable, Mechanical	INN	4
Introducer, Syringe Needle	KZH	4
Medical Device Data System	OUG	3
Reagents, Specific, Analyte	MVU	3
Warmer, Blood, Non-Electromagnetic Radiation	BSB	3
Warmer, Thermal, Infusion Fluid	LGZ	3
Bag, Urine Collection, Leg, For External Use, Non-Sterile	NNW	3
Adaptor, Hygiene	ILS	3
Dressing, Wound, Occlusive	NAD	3
System, Image Processing, Radiological	LLZ	3
Collector, Ostomy	EXB	3
Bag, Drainage, With Adhesive, Ostomy	FON	3
Masker, Tinnitus	KLW	3
Hearing Aid, Air-Conduction With Wireless Technology, Prescription	OSM	3
Otoscope	ERA	3
Walker, Mechanical	ITJ	3
System, Nuclear Magnetic Resonance Imaging	LNH	3
Accessories, Wheelchair	KNO	3
Lift, Patient, Non-Ac-Powered	FSA	3
Table, Powered	INQ	3
Calibrator, Hearing Aid / Earphone And Analysis Systems	ETW	3
Stimulator, Auditory, Evoked Response	GWJ	3
Cushion, Earphone (For Audiometric Testing)	ETT	3
Tester, Auditory Impedance	ETY	3
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	JQC	2
Counter, Differential Cell	GKZ	2
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	2
Research Use Only/Pathology	OTU	2
General Purpose Reagent	PPM	2
Wire, Guide, Catheter	DQX	2
Needle, Hypodermic, Single Lumen	FMI	2
Powered Laser Surgical Instrument	GEX	2
Accessories, Implant, Dental, Endosseous	NDP	2
Dressing, Wound, Hydrophilic	NAC	2
I.V. Start Kit	LRS	2
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2
Peripheral Blood Processing Device For Wound Management	PMQ	2
Labware, Assisted Reproduction, Exempt	PUD	2
Handle, Instrument, Dental	EJB	2
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	2
Forceps	HTD	2
Container, Specimen, Non-Sterile	NNI	2
Garment, Protective, For Incontinence	EYQ	2
Automated Radiological Image Processing Software	QIH	2
Cable, Electrode	IKD	2
Cystoscope And Accessories, Flexible/Rigid	FAJ	2
Container, Specimen, Sterile	FMH	2
Chair, With Casters	INM	2
Tube, Collection, Capillary Blood	GIO	2
Dental Abutment Design Software For Dental Laboratory	PNP	2
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2
System, Tomography, Computed, Emission	KPS	2
Stimulator, Electrical, Evoked Response	GWF	2
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2
Interventional Fluoroscopic X-Ray System	OWB	2
Bandage, Liquid, Skin Protectant	NEC	2
Face Plate Hearing Aid	LRB	2
Sling, Arm, Overhead Supported	ILE	2
Nystagmograph	GWN	2
Table, Mechanical	INW	2
Electrode, Cutaneous	GXY	2
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	QUG	2
Media, Reproductive	MQL	2
Apparatus, Vestibular Analysis	LXV	2
Stimulator, Caloric-Air	KHH	2
Coronary Artery Disease Risk Indicator From Acoustic Heart Signals	QMW	2
Electrosurgical, Cutting & Coagulation & Accessories	GEI	1
Syringe, Piston	FMF	1
Dressing, Wound, Drug	FRO	1
Methyl Methacrylate For Cranioplasty	GXP	1
Drill, Bone, Powered	DZI	1
Nasopharyngoscope (Flexible Or Rigid)	EOB	1
Neurological Stereotaxic Instrument	HAW	1
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1
Diazo Colorimetry, Bilirubin	CIG	1
Calibrator, Multi-Analyte Mixture	JIX	1
Calibrator, Secondary	JIT	1
Glucose Oxidase, Glucose	CGA	1
Electrode, Ion Specific, Potassium	CEM	1
Electrode, Ion-Specific, Chloride	CGZ	1
Electrode, Ion Specific, Sodium	JGS	1
Test, Cystatin C	NDY	1
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1
Controls For Blood-Gases, (Assayed And Unassayed)	JJS	1
Albumin, Fitc, Antigen, Antiserum, Control	DDZ	1
Slide Stainer, Automated	KPA	1
Prealbumin, Antigen, Antiserum, Control	JZJ	1
Immunohistochemistry Assay, Antibody, Progesterone Receptor	MXZ	1
Igm, Fitc, Antigen, Antiserum, Control	DFS	1
Immunohistochemistry Reagents And Kits	NJT	1
System, Test, Beta-2-Microglobulin Immunological	JZG	1
Igg, Fitc, Antigen, Antiserum, Control	DGK	1
Eosin Y	HYB	1
Lambda, Fitc, Antigen, Antiserum, Control	DES	1

Makers in Denmark

Best documented first: most 510(k) clearances and PMA approvals.

Maker	Location	Device types	510(k) clearances	PMA approvals	Recall events	Source
Origio A/S	Ballerup Hovedstaden, Denmark	2	46	0	0	api.fda.gov
Ambu A/S	Ballerup Hovedstaden, Denmark	28	37	0	0	api.fda.gov
Scandinavian Medical Solutions A/S	Aalborg Nordjylland, Denmark	11	34	0	0	api.fda.gov
Interacoustics A/S	Middelfart Syddanmark, Denmark	16	32	0	0	api.fda.gov
Agilent Technologies Denmark ApS	GLOSTRUP Hovedstaden, Denmark	41	28	2	4	api.fda.gov
Coloplast A/S	HUMLEBAEK Hovedstaden, Denmark	22	21	0	0	api.fda.gov
Radiometer Medical Aps	BROENSHOEJ Hovedstaden, Denmark	26	21	0	18	api.fda.gov
Natus Medical Denmark ApS	TAASTRUP Hovedstaden, Denmark	14	18	0	2	api.fda.gov
Tonica Elektronik A/S	FARUM Hovedstaden, Denmark	6	18	0	0	api.fda.gov
Elos Medtech Pinol A/S	Goerloese Hovedstaden, Denmark	9	14	0	0	api.fda.gov
Unomedical A/S	OSTED, LEJRE Sjaelland, Denmark	3	14	0	6	api.fda.gov
3Shape A/S	Copenhagen Hovedstaden, Denmark	5	8	0	0	api.fda.gov
LiNA Medical ApS	Naerum Hovedstaden, Denmark	14	8	0	0	api.fda.gov
Novo Nordisk A/S	HILLEROED Hovedstaden, Denmark	4	8	0	0	api.fda.gov
Novo Nordisk A/S - Needle Manufacturing And Sourci	HJOERRING Nordjylland, Denmark	1	8	0	0	api.fda.gov
Vitrolife A/S	Viby J Midtjylland, Denmark	5	8	0	0	api.fda.gov
William Cook Europe Aps	BJAEVERSKOV Sjaelland, Denmark	5	6	2	0	api.fda.gov
BK Medical Aps	HERLEV Hovedstaden, Denmark	5	7	0	5	api.fda.gov
AMS Denmark ApS	Hundested Hovedstaden, Denmark	2	5	0	0	api.fda.gov
Cercare Medical A/S	Aarhus Midtjylland, Denmark	2	5	0	0	api.fda.gov
Mermaid Medical A/S	Stenloese Hovedstaden, Denmark	7	4	0	2	api.fda.gov
Norlase Aps	Ballerup Hovedstaden, Denmark	2	4	0	0	api.fda.gov
X3D Aps	Kvistgaard Hovedstaden, Denmark	2	4	0	0	api.fda.gov
3shape Trios A/S	copenhagen Hovedstaden, Denmark	3	3	0	0	api.fda.gov
AdvaLight APS	Ballerup Hovedstaden, Denmark	1	3	0	0	api.fda.gov
GN Hearing A/S	BALLERUP Hovedstaden, Denmark	7	3	0	1	api.fda.gov
NRT X-Ray A/S	HASSELAGER Midtjylland, Denmark	2	3	0	4	api.fda.gov
Ronvig Dental MFG. A/S	DAUGAARD Midtjylland, Denmark	9	3	0	0	api.fda.gov
Cimpax A/S	Slangerup Hovedstaden, Denmark	2	2	0	0	api.fda.gov
Cortex Technology Aps	Aalborg Nordjylland, Denmark	2	2	0	0	api.fda.gov
Mequ A/S	Copenhagen Hovedstaden, Denmark	2	2	0	0	api.fda.gov
Motilitycount Aps	Valby Hovedstaden, Denmark	2	2	0	0	api.fda.gov
Powermedic Aps	HOLBAEK Sjaelland, Denmark	1	2	0	0	api.fda.gov
R82 A/S	GEDVED Midtjylland, Denmark	9	2	0	4	api.fda.gov
TracInnovations A/S	Ballerup Hovedstaden, Denmark	1	2	0	0	api.fda.gov
Acarix AS	Hellerup Hovedstaden, Denmark	1	1	0	0	api.fda.gov
Asicomo A/S	Rodby Sjaelland, Denmark	1	1	0	0	api.fda.gov
Bioporto Diagnostics A/S	Hellerup Hovedstaden, Denmark	1	1	0	1	api.fda.gov
Brainreader	Aalborg Nordjylland, Denmark	2	1	0	1	api.fda.gov
Cathvision Aps	Copenhagen NV Hovedstaden, Denmark	1	1	0	0	api.fda.gov
CMS Dental A/S	Roslev Midtjylland, Denmark	2	1	0	0	api.fda.gov
Eldon Biologicals A/S	GENTOFTE Hovedstaden, Denmark	1	1	0	0	api.fda.gov
Ferrosan Medical Devices A/S	Soeborg Hovedstaden, Denmark	1	0	1	0	api.fda.gov
Immudex, Aps	Virum Hovedstaden, Denmark	3	1	0	0	api.fda.gov
Oticon A/S	Smorum Hovedstaden, Denmark	4	1	0	0	api.fda.gov
SSI Diagnostica A/S	Hilleroed Hovedstaden, Denmark	11	1	0	0	api.fda.gov
Union Medico Aps	Copenhagen Hovedstaden, Denmark	1	1	0	0	api.fda.gov
Ward 24/7	Copenhagen K Hovedstaden, Denmark	1	1	0	0	api.fda.gov
WS Audiology A/S	Lynge Hovedstaden, Denmark	3	1	0	1	api.fda.gov
A/S Kurt Hansen	Svendborg Syddanmark, Denmark	2	0	0	0	api.fda.gov
Abena International A/S	AABENRAA Syddanmark, Denmark	5	0	0	0	api.fda.gov
Airofit A/S	Copenhagen Hovedstaden, Denmark	1	0	0	0	api.fda.gov
AllMatters APS	Copenhagen Hovedstaden, Denmark	1	0	0	0	api.fda.gov
Auditdata A/S	Copenhagen Hovedstaden, Denmark	4	0	0	0	api.fda.gov
Bellinger A/S	RISSKOV Midtjylland, Denmark	1	0	0	0	api.fda.gov
Biopsafe Aps	Vedbaek Hovedstaden, Denmark	1	0	0	0	api.fda.gov
By Acre Aps	Copenhagen Hovedstaden, Denmark	3	0	0	0	api.fda.gov
Codan Medical Aps.	ROEDBY Sjaelland, Denmark	1	0	0	0	api.fda.gov
Contura International A/S	Soeborg Hovedstaden, Denmark	1	0	0	0	api.fda.gov
Coremedtech Aps	Allerod Hovedstaden, Denmark	1	0	0	0	api.fda.gov
Canon Medical Informatics A/S	Valby Hovedstaden, Denmark	1	0	0	0	api.fda.gov
Coloplast A/S - Mordrup Site	Espergaerde Hovedstaden, Denmark	2	0	0	0	api.fda.gov
Design Eyewear Group International A/S	Tranbjerg Midtjylland, Denmark	2	0	0	0	api.fda.gov
Ergodenta Aps	Taastrup Hovedstaden, Denmark	35	0	0	0	api.fda.gov
Etac Immedia A/S	Gedved Midtjylland, Denmark	1	0	0	0	api.fda.gov
Examvision A/S	samsoe Midtjylland, Denmark	2	0	0	0	api.fda.gov
Elcold Frysere. Hobro ApS	Hobro Nordjylland, Denmark	1	0	0	0	api.fda.gov
Etac A/S	Gedved Midtjylland, Denmark	3	0	0	4	api.fda.gov
Furine Aps	Skaevinge Hovedstaden, Denmark	3	0	0	0	api.fda.gov
Fleye Aps	Hedehusene Hovedstaden, Denmark	1	0	0	0	api.fda.gov
GP Medical Devices A/S	Holstebro Midtjylland, Denmark	3	0	0	0	api.fda.gov
Henrotek A/S	Roedding Syddanmark, Denmark	1	0	0	0	api.fda.gov
Innoventa Medica	Birkeroed Hovedstaden, Denmark	1	0	0	0	api.fda.gov
Kementec Solutions AS	Taastrup Hovedstaden, Denmark	1	0	0	0	api.fda.gov
KEN Hygiene Systems A/S	Broby Syddanmark, Denmark	1	0	0	0	api.fda.gov
Knudsen Plast A/S	Frederiksvaerk Hovedstaden, Denmark	1	0	0	0	api.fda.gov
Levitate Technology Aps	Herlev Hovedstaden, Denmark	1	0	0	0	api.fda.gov
Liftup A/S	Stoevring Nordjylland, Denmark	1	0	0	0	api.fda.gov
Lindberg A/S	AABYHOJ Midtjylland, Denmark	3	0	0	0	api.fda.gov
Lizn Aps	Risskov Midtjylland, Denmark	1	0	0	0	api.fda.gov
Monoqool	Fredensborg Sjaelland, Denmark	2	0	0	0	api.fda.gov
Novo Nordisk A/S	Kalundborg Sjaelland, Denmark	1	0	0	0	api.fda.gov
Nunc A/S	ROSKILDE Sjaelland, Denmark	2	0	0	0	api.fda.gov
Oscilla A/S	8200 Midtjylland, Denmark	1	0	0	0	api.fda.gov
Paul E. Danchell A/S	Jyderup Sjaelland, Denmark	15	0	0	0	api.fda.gov
PCG Aps	Rungsted Kyst Hovedstaden, Denmark	1	0	0	0	api.fda.gov
Pressalit	Ry Midtjylland, Denmark	7	0	0	0	api.fda.gov
Phillips-Medisize A/S	STRUER Midtjylland, Denmark	2	0	0	0	api.fda.gov
Reapplix	Birkerod Sjaelland, Denmark	2	0	0	0	api.fda.gov
Ropox A/S	Naestved Sjaelland, Denmark	4	0	0	0	api.fda.gov
Rotobed	Lunderskov, Denmark	3	0	0	0	api.fda.gov
Sarstedt Aps	Bording Midtjylland, Denmark	1	0	0	0	api.fda.gov
Skans Aps	Copenhagen Hovedstaden, Denmark	2	0	0	0	api.fda.gov
Sparmed Aps	Farum Hovedstaden, Denmark	2	0	0	0	api.fda.gov
Tytex Denmark A/S	IKAST Midtjylland, Denmark	7	0	0	0	api.fda.gov
V. Guldmann A/S	AARHUS N Midtjylland, Denmark	4	0	0	0	api.fda.gov
Vela Vermund Larsen A/S	Aalborg SV Nordjylland, Denmark	4	0	0	0	api.fda.gov
Vitrex Medical A/S	HERLEV Hovedstaden, Denmark	2	0	0	0	api.fda.gov
Winncare Nordic ApS	KORSOR Sjaelland, Denmark	1	0	0	0	api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.