Brazil Medical Device Registry Statistics
Aggregated from 100,149 official ANVISA registration records covering 12,442 manufacturers from 68 countries. Data as of 2026-08-26.


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Registrations by Technical Category
Largest technical category groups among registrations
| Technical Category | Registrations | Share |
|---|---|---|
| Surgical instruments | 3,277 | 3.3% |
| Instrument Kit | 2,069 | 2.1% |
| Catheters | 1,974 | 2.0% |
| Cannulas | 1,841 | 1.8% |
| Surgical Kit | 1,833 | 1.8% |
| Tampões, Diluentes E Demais Soluções Para Análise Laboratorial | 1,833 | 1.8% |
| Surgical Apparel | 1,149 | 1.1% |
| Combined Parameters In The Same Product - Class Ii | 1,138 | 1.1% |
| Masks | 1,012 | 1.0% |
| Dressing | 999 | 1.0% |
| Instrumental For Orthopedic Implant | 974 | 1.0% |
| Hospital Apparel | 855 | 0.9% |
| Flask Or Material For Collection, Storage Or Transport Of Biological Samples | 853 | 0.9% |
| Disposable Gloves | 802 | 0.8% |
| Needles | 779 | 0.8% |
| Infusion Sets | 773 | 0.8% |
| Probes | 767 | 0.8% |
| Disposable Needles | 730 | 0.7% |
| Disposable Syringes | 619 | 0.6% |
| Gauze Sponges | 608 | 0.6% |
Published Manufacturer Countries
Countries associated with manufacturers in this dataset (top 15); these do not establish individual manufacturing-site locations.
| # | Country | Registrations | Share |
|---|---|---|---|
| 1 | Brazil | 32,063 | 32.0% |
| 2 | China | 20,577 | 20.5% |
| 3 | United States | 15,393 | 15.4% |
| 4 | Germany | 8,490 | 8.5% |
| 5 | Italy | 2,459 | 2.5% |
| 6 | India | 2,175 | 2.2% |
| 7 | France | 2,061 | 2.1% |
| 8 | South Korea | 2,010 | 2.0% |
| 9 | United Kingdom | 1,870 | 1.9% |
| 10 | Switzerland | 1,684 | 1.7% |
| 11 | Japan | 1,342 | 1.3% |
| 12 | Pakistan | 1,002 | 1.0% |
| 13 | Spain | 958 | 1.0% |
| 14 | Argentina | 843 | 0.8% |
| 15 | Taiwan | 792 | 0.8% |
Top 50 Manufacturers in Brazil
Ranked by registrations under published names. Name grouping does not establish legal-entity identity or corporate relationships.
| Rank | Manufacturer | Published country | Registrations | Top categories |
|---|---|---|---|---|
#1 | ROCHE DIAGNOSTICS GMBH | Germany | 768 | Tampões, Diluentes E Demais Soluções Para Análise Laboratorial Combined Parameters In The Same Product - Class Ii Combined Parameters In The Same Product - Class Iii |
#2 | SIEMENS HEALTHCARE DIAGNOSTICS INC. | United States | 456 | Tampões, Diluentes E Demais Soluções Para Análise Laboratorial Combined Parameters In The Same Product - Class Ii Instrument for analysis of general biochemistry, hormones, drugs or proteins |
#3 | MARDEN MEDICAL LTDA | Brazil | 427 | Surgical Kit Instrument Kit Cannulas |
#4 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | China | 412 | Tampões, Diluentes E Demais Soluções Para Análise Laboratorial Lysis Solution Combined Parameters In The Same Product - Class Ii |
#5 | E-MED PRODUTOS MÉDICO-HOSPITALARES LTDA - ME | Brazil | 345 | Instrument Kit Catheters Endoscopic Instruments |
#6 | JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A. | Brazil | 320 | Dental Prosthesis Components Dental Surgical Instruments Surgical Instrument For Dental Implants |
#7 | QUIBASA QUÍMICA BÁSICA LTDA | Brazil | 282 | Coronavirus Combined Parameters In The Same Product - Class Ii Tampões, Diluentes E Demais Soluções Para Análise Laboratorial |
#8 | BOSTON SCIENTIFIC CORPORATION - MARLBOROUGH | United States | 273 | Catheters Penile Prosthesis Endoprótese (Vascular) |
#9 | MEDTRONIC, INC. | United States | 268 | Cannulas Catheters Surgical instruments |
#10 | ORGENTEC DIAGNOSTIKA GMBH | Germany | 266 | Antibody Anti-Extractable Nuclear Antigens (Ena) Antiphospholipid Antibody Antinuclear Antibody (Ana) |
#11 | SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD. | China | 260 | Tampões, Diluentes E Demais Soluções Para Análise Laboratorial Antibody Anti-Extractable Nuclear Antigens (Ena) Herpes Virus (Hhv 4) - Epstein-Barr Virus (Ebv) |
#12 | ABBOTT GMBH | Germany | 254 | Herpes Virus (Hhv 4) - Epstein-Barr Virus (Ebv) Combined Parameters In The Same Product - Class Ii Toxoplasma Gondii |
#13 | LABTEST DIAGNOSTICA S/A | Brazil | 242 | Tampões, Diluentes E Demais Soluções Para Análise Laboratorial Combined Parameters In The Same Product - Class Ii Dengue |
#14 | BIOSYSTEMS S.A. | Spain | 236 | Combined Parameters In The Same Product - Class Ii Total Protein Albumin |
#15 | RICHARD WOLF GMBH | Germany | 233 | Surgical instruments Rigid Endoscope Tubes |
#16 | ABBOTT MEDICAL | United States | 227 | Cardiovascular Guide Wire Cardiovascular Prostheses Stent For Peripheral Arteries |
#17 | RAZEK EQUIPAMENTOS LTDA | Brazil | 222 | Surgical Kit Surgical instruments Surgical Burs |
#18 | AESCULAP AG | Germany | 219 | Surgical instruments Instrument Kit Trochars |
#19 | Eco Diagnostica Ltda | Brazil | 216 | Coronavirus Dengue Combined Parameters In The Same Product - Class Ii |
#20 | WIENER LABORATORIOS S.A.I.C. | Argentina | 204 | Tampões, Diluentes E Demais Soluções Para Análise Laboratorial Combined Parameters In The Same Product - Class Ii Lysis Solution |
#21 | Humanna Medical Ltda | Brazil | 201 | Surgical Kit Cannulas Disposable Blades |
#22 | IN VITRO DIAGNOSTICA LTDA | Brazil | 198 | Tampões, Diluentes E Demais Soluções Para Análise Laboratorial GLYCATED HEMOGLOBIN (HbA1C) Coronavirus |
#23 | BIODINAMICA QUIMICA E FARMACEUTICA LTDA | Brazil | 193 | Resina Composta Fotopolimerizável Material for Root Canal Disinfection and Obturation Dental Whitening Agents |
#24 | KOLPLAST CI LTDA | Brazil | 190 | Flask Or Material For Collection, Storage Or Transport Of Biological Samples Colpocitology Kit Disposable Speculum |
#25 | HANGZHOU ALLTEST BIOTECH CO. LTD | China | 186 | Drugs Of Abuse Panel Dengue Self-Test For Human Chorionic Gonadotropin (Hcg) |
#26 | GOLD ANALISA DIAGNOSTICA LTDA | Brazil | 183 | GLYCATED HEMOGLOBIN (HbA1C) Coronavirus Bilirubin |
#27 | COLOPLAST A/S | Denmark | 181 | Collection Bags Catheters Dressing |
#28 | VYTTRA DIAGNOSTICOS S.A. | Brazil | 181 | Tampões, Diluentes E Demais Soluções Para Análise Laboratorial Combined Parameters In The Same Product - Class Ii Lysis Solution |
#29 | WINNER INDÚSTRIA DE DESCARTÁVEIS LTDA | Brazil | 181 | Surgical Drape Surgical Apparel Surgical Gown Set, Surgical Drape And Gauze Sponge |
#30 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH | Germany | 178 | Tampões, Diluentes E Demais Soluções Para Análise Laboratorial Plasma Deficient In Coagulation Factors Combined Parameters In The Same Product - Class Ii |
#31 | SYNTHES GMBH (OBERDORF) | Switzerland | 178 | Orthopedic Fixation Systems And Associated Devices Surgical instruments Instrument Kit |
#32 | COVIDIEN LLC | United States | 169 | Catheters Probes Dressing |
#33 | KATAL BIOTECNOLOGICA INDÚSTRIA E COMÉRCIO LTDA | Brazil | 169 | Lysis Solution Tampões, Diluentes E Demais Soluções Para Análise Laboratorial Combined Parameters In The Same Product - Class Ii |
#34 | KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA | Brazil | 169 | Combined Parameters In The Same Product - Class Iii Human Chorionic Gonadotropin (Hcg) Total Combined Parameters - Respiratory Panel |
#35 | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | Germany | 162 | Chlamydia Tampões, Diluentes E Demais Soluções Para Análise Laboratorial Toxoplasma Gondii |
#36 | ABBOTT IRELAND DIAGNOSTICS DIVISION | Ireland | 159 | Tampões, Diluentes E Demais Soluções Para Análise Laboratorial Hepatitis B Virus Surface Antigen (Hbsag) Thyroid Stimulating Hormone (Tsh) |
#37 | GM DOS REIS INDUSTRIA E COMERCIO LTDA | Brazil | 157 | Instrumental For Orthopedic Implant Orthopedic Fixation Systems And Associated Devices Non-Bioabsorbable, Non-Sterile Orthopedic Bone Screw |
#38 | KARL STORZ SE & CO. KG | Germany | 156 | Trochars Surgical instruments Tubes |
#39 | BHIO SUPPLY INDUSTRIA E COMERCIO DE EQUIPAMENTOS MEDICOS S/A | Brazil | 153 | Surgical instruments Cannulas Trochars |
#40 | FUJIFILM CORPORATION | Japan | 153 | Flexible Endoscope Gastroduodenoscope Accessories For Endoscopy |
#41 | RENOVA MEDICAL INDÚSTRIA E COMÉRCIO DE PRODUTOS MÉDICOS HOSPITALARES LTDA | Brazil | 152 | Surgical Kit Metal Cannulas Single Administration Nerve Locator Anesthesia Kit |
#42 | SIEMENS HEALTHCARE DIAGNOSTICS INC | United States | 148 | Tampões, Diluentes E Demais Soluções Para Análise Laboratorial Combined Parameters In The Same Product - Class Ii Creatine Kinase Isoenzymes (Ckmb, Ckbb, Ckmm) |
#43 | WAMA PRODUTOS PARA LABORATORIO LTDA | Brazil | 148 | Coronavirus Combined Parameters In The Same Product - Class Ii Rheumatoid Factor |
#44 | BECKMAN COULTER, INC. | United States | 145 | Tampões, Diluentes E Demais Soluções Para Análise Laboratorial Combined Parameters In The Same Product - Class Ii Instrumento para preparo e processamento de amostras – fase pré-analítica |
#45 | PHARMAPLAST S.A.E | Egypt | 145 | Dressing Adhesive Tapes and Bandages Catheter Fixation Device |
#46 | ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA | Brazil | 144 | Protectors Orthopedic Insole Limb Orthosis |
#47 | COOK INCORPORATED | United States | 142 | Catheters Cardiovascular Guide Wire Nephrostomy Set |
#48 | Vida Biotecnologia Ltda - ME | Brazil | 141 | Coronavirus Bilirubin C-Reactive Protein |
#49 | OSTEOMED S.A | Brazil | 140 | Instrumental For Orthopedic Implant Instrumental for Spine Implant Spinal Fusion Cages |
#50 | TECHIMPORT TECNOLOGIA EM IMPLANTES ORTOPEDICOS LTDA | Brazil | 139 | Instrumental For Orthopedic Implant Orthopedic Fixation Systems And Associated Devices Instrument Kit |
Top 50 Registration Holders in Brazil
Published registration holder names ranked by registrations held. Foreign manufacturers cannot register directly with ANVISA — a Brazil Registration Holder (BRH) files and owns the registration on their behalf.
Medical Specialty Reports
Anesthesiology
Cardiovascular
Dental
ENT
Gastro & Urology
General Surgery
General Hospital
Neurology
OB/GYN
Ophthalmic
Orthopedic
Physical Medicine
Radiology
Clinical Chemistry
Hematology
Immunology
What the ANVISA medical device registry shows
The Agência Nacional de Vigilância Sanitária (ANVISA) regulates medical devices in Brazil. As of 2026-08-26, this official dataset snapshot contains 100,149 registration records resolved from 102,826 official source rows at the one registration-to-manufacturer association row grain. The most frequently listed manufacturer name is ROCHE DIAGNOSTICS GMBH with 768 registrations. Brazil is the most represented manufacturer country, accounting for 32,063 registrations (32.0%). The dataset lists 4,217 distinct published registration holder names.
Every figure is computed from the official dataset snapshot as mirrored in the Pure Global database. Registration totals, time trends, risk classes, categories, and company rankings count each registration number once within the displayed dimension; a registration associated with multiple manufacturers may appear once under each relevant manufacturer or published country. 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 Brazil device database, or see our methodology for how the data is collected.