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Medical Device Registry Insights · ANVISA

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.

100,149
Registrations
12,442
Manufacturer names
4,217
Registration Holder names
68
Manufacturer countries
DJ Fang
DJ Fang
MedTech Regulatory Expert

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Pricing
New registrations by year
201520162017201820192020202120222023202420252026
VerifiedANVISA · data as of 2026-08-26
Registrations by risk class
Class IIClass IClass IIIClass IV
VerifiedANVISA · data as of 2026-08-26

Registrations by Technical Category

Largest technical category groups among registrations

Technical CategoryRegistrationsShare
Surgical instruments3,2773.3%
Instrument Kit2,0692.1%
Catheters1,9742.0%
Cannulas1,8411.8%
Surgical Kit1,8331.8%
Tampões, Diluentes E Demais Soluções Para Análise Laboratorial1,8331.8%
Surgical Apparel1,1491.1%
Combined Parameters In The Same Product - Class Ii1,1381.1%
Masks1,0121.0%
Dressing9991.0%
Instrumental For Orthopedic Implant9741.0%
Hospital Apparel8550.9%
Flask Or Material For Collection, Storage Or Transport Of Biological Samples8530.9%
Disposable Gloves8020.8%
Needles7790.8%
Infusion Sets7730.8%
Probes7670.8%
Disposable Needles7300.7%
Disposable Syringes6190.6%
Gauze Sponges6080.6%

Published Manufacturer Countries

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

#CountryRegistrationsShare
1Brazil32,06332.0%
2China20,57720.5%
3United States15,39315.4%
4Germany8,4908.5%
5Italy2,4592.5%
6India2,1752.2%
7France2,0612.1%
8South Korea2,0102.0%
9United Kingdom1,8701.9%
10Switzerland1,6841.7%
11Japan1,3421.3%
12Pakistan1,0021.0%
13Spain9581.0%
14Argentina8430.8%
15Taiwan7920.8%

Top 50 Manufacturers in Brazil

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

RankManufacturerPublished countryRegistrationsTop categories
#1
ROCHE DIAGNOSTICS GMBHGermany768
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 States456
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 LTDABrazil427
Surgical Kit
Instrument Kit
Cannulas
#4
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTDChina412
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 - MEBrazil345
Instrument Kit
Catheters
Endoscopic Instruments
#6
JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.Brazil320
Dental Prosthesis Components
Dental Surgical Instruments
Surgical Instrument For Dental Implants
#7
QUIBASA QUÍMICA BÁSICA LTDABrazil282
Coronavirus
Combined Parameters In The Same Product - Class Ii
Tampões, Diluentes E Demais Soluções Para Análise Laboratorial
#8
BOSTON SCIENTIFIC CORPORATION - MARLBOROUGHUnited States273
Catheters
Penile Prosthesis
Endoprótese (Vascular)
#9
MEDTRONIC, INC.United States268
Cannulas
Catheters
Surgical instruments
#10
ORGENTEC DIAGNOSTIKA GMBHGermany266
Antibody Anti-Extractable Nuclear Antigens (Ena)
Antiphospholipid Antibody
Antinuclear Antibody (Ana)
#11
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.China260
Tampões, Diluentes E Demais Soluções Para Análise Laboratorial
Antibody Anti-Extractable Nuclear Antigens (Ena)
Herpes Virus (Hhv 4) - Epstein-Barr Virus (Ebv)
#12
ABBOTT GMBHGermany254
Herpes Virus (Hhv 4) - Epstein-Barr Virus (Ebv)
Combined Parameters In The Same Product - Class Ii
Toxoplasma Gondii
#13
LABTEST DIAGNOSTICA S/ABrazil242
Tampões, Diluentes E Demais Soluções Para Análise Laboratorial
Combined Parameters In The Same Product - Class Ii
Dengue
#14
BIOSYSTEMS S.A.Spain236
Combined Parameters In The Same Product - Class Ii
Total Protein
Albumin
#15
RICHARD WOLF GMBHGermany233
Surgical instruments
Rigid Endoscope
Tubes
#16
ABBOTT MEDICALUnited States227
Cardiovascular Guide Wire
Cardiovascular Prostheses
Stent For Peripheral Arteries
#17
RAZEK EQUIPAMENTOS LTDABrazil222
Surgical Kit
Surgical instruments
Surgical Burs
#18
AESCULAP AGGermany219
Surgical instruments
Instrument Kit
Trochars
#19
Eco Diagnostica LtdaBrazil216
Coronavirus
Dengue
Combined Parameters In The Same Product - Class Ii
#20
WIENER LABORATORIOS S.A.I.C.Argentina204
Tampões, Diluentes E Demais Soluções Para Análise Laboratorial
Combined Parameters In The Same Product - Class Ii
Lysis Solution
#21
Humanna Medical LtdaBrazil201
Surgical Kit
Cannulas
Disposable Blades
#22
IN VITRO DIAGNOSTICA LTDABrazil198
Tampões, Diluentes E Demais Soluções Para Análise Laboratorial
GLYCATED HEMOGLOBIN (HbA1C)
Coronavirus
#23
BIODINAMICA QUIMICA E FARMACEUTICA LTDABrazil193
Resina Composta Fotopolimerizável
Material for Root Canal Disinfection and Obturation
Dental Whitening Agents
#24
KOLPLAST CI LTDABrazil190
Flask Or Material For Collection, Storage Or Transport Of Biological Samples
Colpocitology Kit
Disposable Speculum
#25
HANGZHOU ALLTEST BIOTECH CO. LTDChina186
Drugs Of Abuse Panel
Dengue
Self-Test For Human Chorionic Gonadotropin (Hcg)
#26
GOLD ANALISA DIAGNOSTICA LTDABrazil183
GLYCATED HEMOGLOBIN (HbA1C)
Coronavirus
Bilirubin
#27
COLOPLAST A/SDenmark181
Collection Bags
Catheters
Dressing
#28
VYTTRA DIAGNOSTICOS S.A.Brazil181
Tampões, Diluentes E Demais Soluções Para Análise Laboratorial
Combined Parameters In The Same Product - Class Ii
Lysis Solution
#29
WINNER INDÚSTRIA DE DESCARTÁVEIS LTDABrazil181
Surgical Drape
Surgical Apparel
Surgical Gown Set, Surgical Drape And Gauze Sponge
#30
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBHGermany178
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)Switzerland178
Orthopedic Fixation Systems And Associated Devices
Surgical instruments
Instrument Kit
#32
COVIDIEN LLCUnited States169
Catheters
Probes
Dressing
#33
KATAL BIOTECNOLOGICA INDÚSTRIA E COMÉRCIO LTDABrazil169
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 LTDABrazil169
Combined Parameters In The Same Product - Class Iii
Human Chorionic Gonadotropin (Hcg) Total
Combined Parameters - Respiratory Panel
#35
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AGGermany162
Chlamydia
Tampões, Diluentes E Demais Soluções Para Análise Laboratorial
Toxoplasma Gondii
#36
ABBOTT IRELAND DIAGNOSTICS DIVISIONIreland159
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 LTDABrazil157
Instrumental For Orthopedic Implant
Orthopedic Fixation Systems And Associated Devices
Non-Bioabsorbable, Non-Sterile Orthopedic Bone Screw
#38
KARL STORZ SE & CO. KGGermany156
Trochars
Surgical instruments
Tubes
#39
BHIO SUPPLY INDUSTRIA E COMERCIO DE EQUIPAMENTOS MEDICOS S/ABrazil153
Surgical instruments
Cannulas
Trochars
#40
FUJIFILM CORPORATIONJapan153
Flexible Endoscope
Gastroduodenoscope
Accessories For Endoscopy
#41
RENOVA MEDICAL INDÚSTRIA E COMÉRCIO DE PRODUTOS MÉDICOS HOSPITALARES LTDABrazil152
Surgical Kit
Metal Cannulas
Single Administration Nerve Locator Anesthesia Kit
#42
SIEMENS HEALTHCARE DIAGNOSTICS INCUnited States148
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 LTDABrazil148
Coronavirus
Combined Parameters In The Same Product - Class Ii
Rheumatoid Factor
#44
BECKMAN COULTER, INC.United States145
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.EEgypt145
Dressing
Adhesive Tapes and Bandages
Catheter Fixation Device
#46
ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDABrazil144
Protectors
Orthopedic Insole
Limb Orthosis
#47
COOK INCORPORATEDUnited States142
Catheters
Cardiovascular Guide Wire
Nephrostomy Set
#48
Vida Biotecnologia Ltda - MEBrazil141
Coronavirus
Bilirubin
C-Reactive Protein
#49
OSTEOMED S.ABrazil140
Instrumental For Orthopedic Implant
Instrumental for Spine Implant
Spinal Fusion Cages
#50
TECHIMPORT TECNOLOGIA EM IMPLANTES ORTOPEDICOS LTDABrazil139
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.

RankRegistration HolderRegistrationsManufacturers represented
#1
VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA2,383382
#2
SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA1,38573
#3
ROCHE DIAGNÓSTICA BRASIL LTDA1,02642
#4
AUTO SUTURE DO BRASIL LTDA.966100
#5
ABBOTT LABORATORIOS DO BRASIL LTDA90053
#6
PASSROD IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS PARA SAÚDE LTDA - ME832150
#7
EMERGO BRAZIL IMPORT IMPORTACAO E DISTRIBUICAO DE PRODUTOS MEDICOS HOSPITALARES LTDA687240
#8
CIRURGICA FERNANDES - COMERCIO DE MATERIAIS CIRURGICOS E HOSPITALARES - SOCIEDADE LIMITADA646184
#9
STRYKER DO BRASIL LTDA63950
#10
VYTTRA DIAGNOSTICOS S.A.63846
#11
ARGOSLAB DISTRIBUIDORA DE PRODUTOS PARA LABORATÓRIOS LTDA63282
#12
JOHNSON & JOHNSON DO BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS PARA SAÚDE LTDA59987
#13
QR CONSULTING, IMPORTACAO E DISTRIBUICAO DE PRODUTOS MEDICOS LTDA56041
#14
LABORATORIOS B. BRAUN S/A51956
#15
JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.48820
#16
BECKMAN COULTER DO BRASIL COMÉRCIO E IMPORTAÇÃO DE PRODUTOS DE LABORATÓRIO LTDA47228
#17
Enzytec Biotecnologia Ltda.44430
#18
MARDEN MEDICAL LTDA4271
#19
MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA42165
#20
BOSTON SCIENTIFIC DO BRASIL LTDA41842
#21
MANDALA BRASIL IMPORTACAO E DISTRIBUICAO DE PRODUTO MEDICO HOSPITALAR LTDA41172
#22
MINDRAY DO BRASIL COMÉRCIO E DISTRIBUIÇÃO DE EQUIPAMENTOS MÉDICOS LTDA.38217
#23
MEDIX BRASIL LTDA371109
#24
Smith & Nephew Comércio de Produtos Médicos Ltda.36840
#25
E-MED PRODUTOS MÉDICO-HOSPITALARES LTDA - ME3547
#26
ZIMMER BIOMET BRASIL LTDA34254
#27
IN VITRO DIAGNOSTICA LTDA3383
#28
PHADIA DIAGNOSTICOS LTDA33727
#29
WINNER INDUSTRIA DE DESCARTAVEIS LTDA33216
#30
BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.32339
#31
EUROIMMUN BRASIL MEDICINA DIAGNOSTICA LTDA31912
#32
BIOSYS LTDA31723
#33
QUIBASA - QUIMICA BASICA LTDA31115
#34
WERFEN MEDICAL LTDA30723
#35
ORTHO CLINICAL DIAGNÓSTICS DO BRASIL PRODUTOS PARA SAÚDE LTDA30016
#36
BIOMÉDICA EQUIPAMENTOS E SUPRIMENTOS HOSPITALARES LTDA29980
#37
CEI COMÉRCIO EXPORTAÇÃO E IMPORTAÇÃO DE MATERIAIS MÉDICOS LTDA29459
#38
LABTEST DIAGNOSTICA S/A29421
#39
CEDRS - GESTAO EMPRESARIAL LTDA28129
#40
ARTHREX DO BRASIL IMPORTACAO E COMERCIO DE EQUIPAMENTOS MÉDICOS LTDA27332
#41
DESCARPACK DESCARTAVEIS DO BRASIL LTDA26994
#42
CIENLABOR INDUSTRIA E COMERCIO LTDA26538
#43
LABORLAB PRODUTOS PARA LABORATÓRIOS LTDA EPP26510
#44
Eco Diagnostica Ltda2509
#45
NUTRIEX IMPORTACAO E EXPORTACAO DE PRODUTOS NUTRICIONAIS E FARMOQUIMICOS LTDA24886
#46
CRAL ARTIGOS PARA LABORATORIO LTDA24072
#47
Vida Biotecnologia Ltda - ME23824
#48
SEBIA IMPORTAÇÕES COMERCIALIZAÇÃO E DISTRIBUIÇÃO DE APARELHOS E REATIVOS PARA DIAGNÓSTICO IN VITRO LTDA.23811
#49
ST. JUDE MEDICAL BRASIL LTDA.23820
#50
Domo Salute Consultoria Regulatória Ltda23672

Top 100 Registration Holders

Companies holding the most ANVISA registrations, all-time and by year.

Top 100 Manufacturers

Global manufacturers with the most ANVISA registrations, all-time and by year.
About the data

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.

VerifiedAgência Nacional de Vigilância Sanitária · 100,149 records · generated 2026-08-26
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