Medical Device Registry Insights · EUDAMED

European Union Medical Device Registry Statistics

Name: European Union Medical Device Registry Statistics
Creator: Pure Global
License: https://creativecommons.org/licenses/by/4.0/

Aggregated from 563,317 official EUDAMED device record records covering 7,750 manufacturers from 75 countries. Data as of 2025-03-11.

563,317

Device records

7,750

Manufacturer names

668

Authorized Representative names

Manufacturer countries

DJ Fang

MedTech Regulatory Expert

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Device records by risk class

Class IClass IIaClass IIbClass IIIClass AIVD – GeneralClass BClass CClass D

VerifiedEUDAMED · data as of 2025-03-11

Device Records by EMDN Category

Largest EMDN category groups among device records

EMDN Category	Device records	Share
Materials For The Preparation Of Custom-Made Dental Devices - Other	22,745	4.0%
Trays, Baskets, Tubs For Sterilisation And Their Components	17,993	3.2%
Various Devices Not Included In Other Classes - Other	9,407	1.7%
Pta Balloon Dilatation Catheters	9,149	1.6%
Intramedullary Nails	8,684	1.5%
Spreaders And Retractors For General Surgery, Reusable - Other	8,569	1.5%
Osteosynthesis Compression Plates	7,682	1.4%
Surgical And Anatomical Tweezers, Reusable	6,572	1.2%
Orthodontic Wires	6,159	1.1%
Orthodontic Brackets And Buttons	5,952	1.1%
IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC	5,369	1.0%
Dental Implants	5,229	0.9%
Non-Extremity Prostheses - Other	4,804	0.9%
Energy Return Ankle-Foot Orthoses	4,476	0.8%
Clinical Procedures Kits Not Included In Other Classes - Other	4,405	0.8%
IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHOBIC ACRYLIC	4,212	0.7%
Resorbable Filling And Reconstruction Devices	4,065	0.7%
Knee Orthoses	4,016	0.7%
Ptca Balloon Dilation Catheters	3,746	0.7%
Surgical Scissors, Reusable - Other	3,670	0.7%

Published Manufacturer Countries

Countries associated with manufacturers in this dataset (top 15); these do not establish individual manufacturing-site locations.

#	Country	Device records	Share
1	China	125,593	22.3%
2	Turkey	118,649	21.1%
3	United States	57,064	10.1%
4	Germany	43,017	7.6%
5	United Kingdom	18,267	3.2%
6	South Korea	17,826	3.2%
7	Pakistan	16,432	2.9%
8	France	16,204	2.9%
9	Poland	13,227	2.3%
10	Italy	12,664	2.2%
11	India	11,078	2.0%
12	Netherlands	11,061	2.0%
13	Spain	10,333	1.8%
14	Taiwan	10,161	1.8%
15	Finland	8,462	1.5%

Device Records by Member State Where Placed On The Market

Device records grouped by member state where placed on the market

#	Member State Where Placed On The Market	Device records	Share
1	Turkey	126,557	22.5%
2	Germany	108,354	19.2%
3	France	41,068	7.3%
4	Netherlands	38,006	6.7%
5	Spain	33,061	5.9%
6	Italy	26,566	4.7%
7	Ireland	25,327	4.5%
8	Portugal	24,778	4.4%
9	Austria	22,787	4.0%
10	Poland	22,677	4.0%
11	Belgium	12,264	2.2%
12	Denmark	8,439	1.5%
13	United Kingdom (Northern Ireland only)	8,278	1.5%
14	Finland	7,975	1.4%
15	Greece	6,527	1.2%
16	Sweden	5,004	0.9%
17	Romania	3,818	0.7%
18	Hungary	3,809	0.7%
19	Slovenia	3,671	0.7%
20	Liechtenstein	3,588	0.6%

Top 50 Manufacturers in European Union

Ranked by device records under published names. Name grouping does not establish legal-entity identity or corporate relationships.

Rank	Manufacturer	Published country	Device records	Top categories
#1	Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi	Turkey	14,861	Osteosynthesis Compression Plates Intramedullary Nails Cancellous Screws
#2	ATLAS CERRAHİ ALETLER LTD. ŞTİ.	Turkey	12,769	Trays, Baskets, Tubs For Sterilisation And Their Components Spreaders And Retractors For General Surgery, Reusable - Other Surgical And Anatomical Tweezers, Reusable
#3	SAMSUN CERRAHİ ALETLER SANAYİ VE TİCARET LİMİTED ŞİRKETİ	Turkey	12,711	Trays, Baskets, Tubs For Sterilisation And Their Components Spreaders And Retractors For General Surgery, Reusable - Other Surgical And Anatomical Tweezers, Reusable
#4	VITA Zahnfabrik	Germany	12,374	Materials For The Preparation Of Custom-Made Dental Devices - Other Dental Implants - Accessories Dental Implants
#5	SAMSUN MİCRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ	Turkey	12,105	Trays, Baskets, Tubs For Sterilisation And Their Components Spreaders And Retractors For General Surgery, Reusable - Other Surgical And Anatomical Tweezers, Reusable
#6	AST VisionCare Inc.	United States	10,470	IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHOBIC ACRYLIC IOLs, APHAKIC, MULTIFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
#7	Becker Orthopedic Appliance Company	United States	10,388	Energy Return Ankle-Foot Orthoses Knee Orthoses External Prostheses And Orthoses - Other
#8	Asel Tibbi Aletler A.S.	Turkey	9,862	Spreaders And Retractors For General Surgery, Reusable - Other Surgical And Anatomical Tweezers, Reusable Trays, Baskets, Tubs For Sterilisation And Their Components
#9	Daddy D Pro	Pakistan	8,810	Surgical Dental Devices - Other Surgical Scissors, Reusable - Other Vein Stripper Systems - Other
#10	Tianjin Zhengtian Medical Instrument Co., Ltd.	China	7,828	Osteosynthesis Compression Plates Thoracolumbosacral Fixation Systems Cortical Screws
#11	ChM spółka z ograniczoną odpowiedzialnością	Poland	7,483	Instruments For Insertion And Extraction Of Materials For Osteosynthesis, Reusable Osteosynthesis Instruments, Reusable - Other Orthopaedic And Traumatological Surgery Instruments, Reusable - Other
#12	TEKNO-CER CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ	Turkey	6,039	Trays, Baskets, Tubs For Sterilisation And Their Components Cannulas And Tips For Aspiration And Irrigation, Single-Use Needle Holders, Reusable
#13	BrosMed Medical Co., Ltd	China	6,022	Pta Balloon Dilatation Catheters Ptca Balloon Dilation Catheters Urological Guidewires, Not Hydrophilic
#14	Bonegraft Biomaterials Co.	Turkey	5,630	Resorbable Filling And Reconstruction Devices Osteosynthesis Devices, Biodegradable Screws And Bars Interference Screws
#15	Ortimplant Ortopedi ve Tıbbi Aletleri Sanayi Ticaret Limited Şirketi	Turkey	5,465	Intramedullary Nails Osteosynthesis Compression Plates Cortical Screws
#16	Tulpar Tıbbi Ürünler İthalat İhracat Sanayi ve Ticaret L.T.D Ş.T.İ	Turkey	5,143	Anchors, Tendon And Ligament Synthesis Osteosynthesis Devices, Biodegradable Screws And Bars Specialist Surgical Instruments And Kits Not Included In Other Classes, Single-Use - Other
#17	ASTAR ORTHODONTICS INC.	China	5,141	Orthodontic Brackets And Buttons Orthodontic Wires Orthodontic Devices - Other
#18	ellen wille THE HAIR-COMPANY GmbH	Germany	4,803	Non-Extremity Prostheses - Other
#19	Shenzhen Yurucheng Dental Materials Co., Ltd.	China	4,720	Materials For The Preparation Of Custom-Made Dental Devices - Other
#20	Medica Europe B.V.	Netherlands	4,669	Clinical Procedures Kits Not Included In Other Classes - Other Surgical Drapes - Other Specialistic Surgery Drapes
#21	İDOL HASTANE ÜRÜN. SAN. VE TİC. A.Ş.	Turkey	4,636	Laparoscopic And Thoracoscopic Surgery Forceps Reusable Laparoscopic And Thoracoscopic Surgery Spreaders And Retractors, Reusable Laparoscopic And Thoracoscopic Surgery Manipulators, Reusable
#22	Zimed Medikal Sanayi ve Ticaret Limited Şirketi	Turkey	4,198	Intramedullary Nails Bone Fixation Plates - Other Bone Fixation Screws, Tendon And Ligament Synthesis Screws - Other
#23	Innovative Material and Devices, Inc	China	4,188	Orthodontic Wires Endodontic Instruments (Canal Enlargers, Files, Rasps, Etc.), Single-Use Orthodontic Brackets And Buttons
#24	ArjoHuntleigh AB	Sweden	3,904	Semi-Intensive Therapy Or Cardiac Intensive Care Units (Cicu) Electric Medical Beds Non Active Anti-Decubitus Medical Mattresses Electric Mobile Lifts
#25	Meril Life Sciences Pvt. Ltd.	India	3,725	Ptca Balloon Dilation Catheters Coronary Drug Eluting Stents (Des) With Polymers Non-Stainless Steel Peripheral Vascular Bare Metal Stents
#26	Woo Young Medical Co., Ltd.	South Korea	3,520	Elastomeric Systems - Variable Flow With Additional Bolus Elastomeric Systems - Fixed Flow With Additional Bolus Elastomeric Systems - Fixed Flow W/O Additional Bolus
#27	Polident d.o.o. Industrija dentalnih proizvodov	Slovenia	3,343	Materials For The Preparation Of Custom-Made Dental Devices - Other
#28	Edenta Etablissement	Liechtenstein	3,237	Dental Drills Odontostomatology Burs, Reusable Dental Abrasive And Polishing Materials
#29	United Orthopedic Corporation	Taiwan	2,850	Bicompartmental Primary Implant Fixed Bearing Tibial Inserts Primary Implant Uncemented Metal Acetabular Cups Bicompartmental Primary Implant Tibial Components, Monoblock Made Of Polyethylene
#30	Alps South, LLC	United States	2,839	Lower Extremity Prostheses - Other Socks For Prostheses Transtibial Prostheses (For Amputation Under Knee)
#31	GOLD ORTOPEDİ SANAYİ VE TİCARET LİMİTED ŞİRKETİ	Turkey	2,759	Intramedullary Nails Bone Fixation Plates - Other Bone Fixation Screws, Tendon And Ligament Synthesis Screws - Other
#32	Hangzhou AGS MedTech Co.,Ltd.	China	2,625	Digestive Endoscopy, Haemostasis Clips Digestive Endoscopy, Single-Lumen Needles Oesophageal Balloon Catheters, Low Pressure
#33	HASA OPTIX	Belgium	2,498	Ophthalmic Surgery Forceps, Single-Use Ophthalmic Surgery Instrument Kits, Single-Use Ophthalmic Surgery Scissors, Single-Use
#34	Maquet SAS	France	2,374	Fixed Scialytic Lamps Scialytic Lamp Lighting Systems - Other Mobile Scialytic Lamps
#35	Quality Needles Private Limited	India	2,329	Suture Accessories Suture Devices - Other
#36	Orantech Inc.	China	2,172	Multi-Parameter Monitors - Consumables Pulse Oximeter Sensors Prenatal Diagnostic Instruments - Consumables
#37	Hangzhou DTC Medical Apparatus Co.,Ltd	China	1,992	Orthodontic Brackets And Buttons Orthodontic Wires Pre-Formed Dental Crowns
#38	GRI Medical & Electronic Technology Co., Ltd.	China	1,913	Incision Drapes, Without Antibacterial Agent Standard Surgical Gowns Non-Surgical Gowns (Excluding Personal Protective Equipment - Ppe)
#39	La Pointique Int´l Ltd.	United States	1,843	Lower Extremity Orthoses - Other Orthoses, Upper Extremity - Other Spine Orthoses - Other
#40	OPPO Medical Inc.	United States	1,835	Lower Extremity Orthoses - Other Orthoses, Upper Extremity - Other Compression Stockings
#41	CV ANGRREK LIAR	Indonesia	1,830	General Medicine Diagnosis And Monitoring Instruments - Hardware Accessories
#42	SIFI S.p.A.	Italy	1,824	IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHILIC ACRYLIC IOLs, APHAKIC, MULTIFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
#43	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	China	1,813	Multidisciplinary Ultrasound Scanners (Internal And Cardiology, Etc.) Portable Ultrasound Scanners Cbc-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-Fluids)
#44	FATMA CEYLAN- CEYLAN MEDİKAL İMALAT İTHALAT İHRACAT DIŞ TİCARET	Turkey	1,790	Trays, Baskets, Tubs For Sterilisation And Their Components
#45	Maccura Biotechnology Co., Ltd.	China	1,784	Coronavirus Auto-Immune Disease Tests - Other Rheumatoid Factors
#46	OPPO Medical Corp.	Taiwan	1,782	Lower Extremity Orthoses - Other Orthoses, Upper Extremity - Other Compression Stockings
#47	groupe lépine	France	1,771	Orthopaedic Prostheses Positioners, Reusable Orthopaedic And Traumatological Surgery Instruments, Reusable - Other Orthopaedic Surgery Rasps, Reusable
#48	Innomed, Inc.	United States	1,754	Spreaders And Retractors For Orthopaedic Surgery, Reusable Non-Implantable Orthopaedic Devices Extractors, Reusable Orthopaedic And Traumatological Surgery Instruments, Reusable - Other
#49	Camp Scandinavia AB	Sweden	1,751	Energy Return Ankle-Foot Orthoses Wrist-Hand Orthoses Knee Orthoses
#50	EUROPACK ULUSLARARASI SAĞLIK VE SPOR ÜRÜNLERI ANONİM ŞİRKETİ	Turkey	1,741	Various Devices Not Included In Other Classes - Other Compression Stockings Elastic Compression Bandages - Other

Top 50 Authorized Representatives in European Union

Published authorized representative names ranked by device records held. Non-EU manufacturers must appoint an EU Authorized Representative; EU-based manufacturers do not, so only about half of the records carry one.

Rank	Authorized Representative	Device records	Manufacturers represented
#1	Shanghai International Holding Corp. GmbH(Europe)	25,946	265
#2	Emergo Europe B.V.	16,387	249
#3	Lotus NL B.V.	15,278	222
#4	SUNGO Europe B.V.	14,569	837
#5	MDSS GmbH	14,120	95
#6	Obelis s.a.	12,012	133
#7	ANTEX MEDI SOLUTION	11,949	16
#8	Advena Limited	11,924	169
#9	MedPath GmbH	10,782	230
#10	Acorn Regulatory Consultancy Services Ltd	10,693	7
#11	Medical Technology Promedt Consulting GmbH	9,372	50
#12	Bricon GmbH	7,792	1
#13	CMC Medical Devices & Drugs SL	6,149	136
#14	Brosmed Medical B.V.	6,022	1
#15	BIO CONCEPT, UNIPESSOAL, LDA	5,141	1
#16	Umedwings Netherlands B.V.	4,692	31
#17	CEpartner4U	4,515	50
#18	mdi Europa GmbH	4,345	32
#19	KTR Europe GmbH	2,717	22
#20	Meddevices Lifesciences B.V.	2,388	8
#21	MEDIMARK EUROPE	2,357	14
#22	Sungo Cert GmbH	2,286	97
#23	MedNet EC-REP GmbH	2,280	100
#24	AR Experts B.V.	2,232	12
#25	Medten EU ApS	2,172	1
#26	Kingsmead Service B.V.	1,995	73
#27	Luxus Lebenswelt GmbH	1,974	45
#28	RIOMAVIX SOCIEDAD LIMITADA	1,910	101
#29	Kaio-Dia	1,830	1
#30	Europecert UG (haftungsbeschränkt)	1,817	9
#31	JaviTech e.K.	1,742	22
#32	Young Microbrush Ireland Ltd	1,708	6
#33	EYEVAN Europe	1,653	1
#34	MedEnvoy Global BV	1,610	33
#35	Wellkang Ltd	1,556	70
#36	Share Info Consultant Service LLC	1,500	8
#37	MPS Medical Product Service GmbH	1,497	13
#38	Prolinx GmbH	1,489	28
#39	Covision Medical Technologies (Ireland) Limited	1,450	1
#40	E C REP LIMITED	1,207	6
#41	Beckman Coulter Ireland Inc.	1,154	3
#42	Medical Device Management Ltd	1,126	7
#43	Southern Implants Europe AB	1,100	1
#44	Exact Medical Manufacturing B.V.	1,084	1
#45	Quality First International OÜ	1,068	3
#46	G. van Wageningen B.V.	1,067	2
#47	Top Glove Europe GmbH	1,049	3
#48	Cinterqual-Soluções de Comércio Internacional,Lda.	1,049	5
#49	KHANG BAO INTERNATIONAL KFT	995	12
#50	Caretechion GmbH	978	49

About the data

What the EUDAMED medical device registry shows

The European Database on Medical Devices (EUDAMED) (EUDAMED) regulates medical devices in European Union. As of 2025-03-11, this official dataset snapshot contains 563,317 device record records. The most frequently listed manufacturer name is Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi with 14,861 device records. China is the most represented manufacturer country, accounting for 125,593 device records (22.3%). The dataset lists 668 distinct published authorized representative names.

Every figure is computed from the official dataset snapshot as mirrored in the Pure Global database. Published company names are grouped by whitespace and case. These name counts do not establish distinct legal entities or corporate relationships. Product and category labels use the derived English value when the current row has one and otherwise preserve the official source-language value. Browse individual records in the searchable European Union device database, or see our methodology for how the data is collected.

VerifiedEuropean Database on Medical Devices (EUDAMED) · 563,317 records · generated 2026-08-26

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