Registry Insights · EUDAMED
European Union Medical Device Registry Statistics
Aggregated from 563,317 official EUDAMED device record records covering 7,750 manufacturers from 75 countries. Data as of 2025-03-11.
The European Database on Medical Devices (EUDAMED) (EUDAMED) regulates medical devices in European Union. As of 2025-03-11, this registry snapshot contains 563,317 device record records.
The largest manufacturer by device records is Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi with 14,861 device records. China is the largest country of origin, accounting for 125,593 device records (22.3%). The registry lists 668 distinct authorized representatives.
Every figure on this page is computed from the official registry snapshot. Browse individual records in the searchable European Union device database, or see our methodology for how the data is collected.
563,317
Device records
7,750
Manufacturers
668
Authorized Representatives
75
Origin countries
Device Records by Risk Class
EUDAMED risk classification of device records
| Risk class | Device records | Share |
|---|---|---|
| Class I | 287,858 | 51.1% |
| Class IIa | 115,323 | 20.5% |
| Class IIb | 82,178 | 14.6% |
| Class III | 33,062 | 5.9% |
| Class A | 23,391 | 4.2% |
| IVD – General | 15,912 | 2.8% |
| Class B | 1,902 | 0.3% |
| Class C | 1,895 | 0.3% |
| Class D | 67 | 0.0% |
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% |
Manufacturer Countries of Origin
Where devices registered in European Union are manufactured (top 15)
| # | 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. Company names are normalized; affiliated legal entities are listed separately, as registered.
| Rank | Manufacturer | Origin | 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
Local authorized representatives 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.
About this data: statistics are computed from the official European Database on Medical Devices (EUDAMED) registry as mirrored in the Pure Global database (563,317 records, newest registration dated 2025-03-11; page generated 2026-08-05). Company names are normalized for whitespace and case, but distinct legal entities of the same group are counted separately. See methodology.