Manufacturer Intelligence · Based on 59,109 FDA 510(k) records · 74 countries

FDA 510(k) Medical Device Manufacturers - Denmark

Name: FDA 510(k) Medical Device Manufacturers
Creator: 510k Database

Danish medical device manufacturers ranked by FDA 510(k) submission volume. This is not a curated directory - rankings reflect real submission activity extracted from FDA accessdata.gov records.

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Manufacturers

Denmark

Country

Denmark FDA 510(k) Overview

Manufacturers

Submissions

98%

Clearance rate

Leading Denmark FDA 510(k) manufacturers include Elos Medtech Pinol A/S, Tonica Elektronik A/S, William Cook Europe Aps and 41 others.

Danish medical device manufacturers have submitted 99 FDA 510(k) notifications since 2018, achieving a 98% clearance rate across 43 manufacturers. Denmark's medtech sector reflects the country's specialization in hearing instruments, diabetes management devices and advanced diagnostics, with a historically high per-capita medical device innovation rate.

Active in FDA 510(k) submissions since 2018. Many Denmark manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) Denmark Manufacturers

1–44 of 44

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Elos Medtech Pinol A/S Goerloese	13	100%	DE	DK
2	Tonica Elektronik A/S Farum	8	100%	NE PM	DK
3	William Cook Europe Aps Bjaeverskov	6	100%	AN CV	DK
4	Bk Medical Aps Herlev	5	100%	RA	DK
5	Radiometer Medicals Aps Br?nsh?j	5	100%	CH	DK
6	3Shape A/S Copenhagen	4	100%	DE	DK
7	GN Hearing A/S Ballerup	4	100%	EN	DK
8	Unomedical A/S Roskilde	3	100%	CH HO	DK
9	Vitrolife A/S Viby J	3	100%	OB	DK
10	Norlase Aps Ballerup	3	100%	OP	DK
11	Artsmedia Denmark Aps Virum	3	100%	OB	DK
12	3Shape TRIOS A/S Copenhagen	3	100%	DE	DK
13	Cercare Medical A/S Aarhus	3	100%	RA	DK
14	Ellipse A/S Hoersholm	2	100%	SU	DK
15	Nrt X-Ray A/S Hasselager	2	100%	RA	DK
16	Motilitycount Aps Valby	2	100%	HE OB	DK
17	Cath Vision Aps Copenhagen N	2	100%	CV	DK
18	Wsaud A/S Lynge	2	100%	EN	DK
19	Mequ A/S Kobenhavn N	2	100%	HO	DK
20	3Shape Medical A/S Copenhagen	1	100%	RA	DK
21	Fbc Device Aps Risskov	1	100%	OR	DK
22	Acarix A/S Hellerup	1	0%	CV	DK
23	Cosmed Nordic Aps Odense	1	100%	AN	DK
24	Ssi Diagnostica A/S Hilleroed	1	100%	MI	DK
25	Cimpax Aps Slangerup	1	100%	AN	DK
26	Mermaid Care A/S Norresundby	1	100%	AN	DK
27	Origio A/S, A Coopersurgical Company M?l?v	1	100%	OB	DK
28	Medilink A/S Kgs. Lyngby	1	100%	SU	DK
29	Cercare Medical Aps Aarhus	1	100%	RA	DK
30	Tracinnovations Aps Ballerup	1	100%	RA	DK
31	Radiobotics Aps Copenhagen	1	100%	RA	DK
32	Neurescue Aps Copenhagen	1	100%	CV	DK
33	Teesuvac Aps Hoersholm	1	100%	SU	DK
34	Nanovi A/S Kgs. Lyngby	1	0%	RA	DK
35	Aw Technologies Aps Norresundby	1	100%	AN	DK
36	Tracinnovations A/S Ballerup	1	100%	RA	DK
37	Bibawo Medical A/S Birker?d	1	100%	SU	DK
38	Norlase Ballerup	1	100%	OP	DK
39	Virtus Technology Aps Roennede	1	100%	AN	DK
40	Inwound Aps Copenhagen	1	100%	SU	DK
41	Ward 24/7 Aps Copenhagen	1	100%	CV	DK
42	Natus Medical Denmark Aps Taastrup	1	100%	EN	DK
43	Go-Pen Aps Kongens Lyngby	1	100%	HO	DK

About This FDA 510(k) Manufacturer Database

Data Source and Methodology

Rankings are based on the total number of published FDA 510(k) submissions per manufacturer in the 510k Database dataset, derived from FDA 510(k) public files. This is not a curated or paid listing - manufacturer rankings reflect real regulatory activity.

Used by regulatory affairs teams and medtech consultants to benchmark manufacturer activity, identify predicate device candidates, and analyze competitive positioning across FDA review panels.