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Medical Device Registry Insights · INVIMA

Colombia Medical Device Registry Statistics

Aggregated from 390,583 official INVIMA registration records covering 9,452 manufacturers from 70 countries. Data as of 2026-08-20.

266,115
Active registrations
9,452
Manufacturer names
4,038
Registration Holder names
70
Manufacturer countries
DJ Fang
DJ Fang
MedTech Regulatory Expert

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Active registrations by risk class
Class IClass IIaClass IIIClass IIbClass II
VerifiedINVIMA · data as of 2026-08-20

Registrations by Product Type

Largest product type groups among active registrations

Product TypeRegistrationsShare
Medico Quirurgicos198,88974.7%
In Vitro Reagents37,32514.0%
Reactivo Diagnostico29,52611.1%
Dental3750.1%

Published Manufacturer Countries

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

#CountryRegistrationsShare
1China20,3947.7%
2United States19,7947.4%
3Colombia13,2145.0%
4Germany5,4552.0%
5Malaysia4,9681.9%
6Mexico4,6611.8%
7United Kingdom2,2760.9%
8Spain1,5940.6%
9France1,5700.6%
10Switzerland1,5270.6%
11Italy1,4950.6%
12Brazil1,4120.5%
13Lithuania1,4010.5%
14India1,3970.5%
15Thailand1,2420.5%

Top 50 Manufacturers in Colombia

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

RankManufacturerPublished countryRegistrationsTop categories
#1
US COTTON MÉXICO S. DE R.L. DE C.V.Mexico2,417
Medico Quirurgicos
#2
LABORATORIOS HIGIETEX S.A.S.Colombia2,411
Medico Quirurgicos
#3
LIFE TECHNOLOGIES CORPORATIONUnited States1,721
In Vitro Reagents
Reactivo Diagnostico
#4
LABORATORIOS HIGIETEX S.A.SColombia1,685
Medico Quirurgicos
#5
THERMO FISHER SCIENTIFIC BALTICS UABLithuania1,295
In Vitro Reagents
Reactivo Diagnostico
#6
PLACECOL S.AColombia963
Medico Quirurgicos
#7
MEDLINE INDUSTRIES, LPUnited States716
Medico Quirurgicos
#8
BOSTON SCIENTIFIC CORPORATIONUnited States619
Medico Quirurgicos
#9
LATEXX MANUFACTURING SDN BHDMalaysia542
Medico Quirurgicos
#10
ROCHE DIAGNOSTICS GMBHGermany528
Reactivo Diagnostico
In Vitro Reagents
Medico Quirurgicos
#11
SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITEDThailand522
Medico Quirurgicos
#12
HARTALEGA NGC SDN BHDMalaysia444
Medico Quirurgicos
#13
LIFE TECHNOLOGIES LTDUnited Kingdom412
In Vitro Reagents
Reactivo Diagnostico
#14
CHENSIN PACKING INDUSTRY CO LTDTaiwan392
Medico Quirurgicos
#15
ZHEJIANG KEKANG MEDICAL TECHNOLOGY CO., LTD.China391
Medico Quirurgicos
#16
IVOCLAR VIVADENT AGLiechtenstein388
Medico Quirurgicos
Dental
#17
ALFA TRADING S.A.S.Colombia381
Medico Quirurgicos
#18
YANGZHOU SANFENG BRUSH CO., LTD.China362
Medico Quirurgicos
#19
YANGZHOU SANXIN BRUSH CO., LTDChina362
Medico Quirurgicos
#20
PESITRO HEALTHCARE PRODUCTS CO., LTD.China357
Medico Quirurgicos
#21
MEDLINE INDUSTRIES, INC.United States354
Medico Quirurgicos
#22
YANGZHOU JUMEI COSMETIC CO., LTDChina353
Medico Quirurgicos
#23
BSN MEDICAL GMBHGermany352
Medico Quirurgicos
#24
YANGZHOU JINGSONG RUBBER & PLASTIC PRODUCTS CO., LTDChina352
Medico Quirurgicos
#25
MEDTRADE PRODUCTS LTDUnited Kingdom347
Medico Quirurgicos
#26
ROCKFORD PIERCE BIOTECHNOLOGY POUnited States343
In Vitro Reagents
#27
MEDLINE INDUSTRIES- MUNDELEINUnited States342
Medico Quirurgicos
#28
FOSHAN UNITED MEDICAL TECHNOLOGIES LTDChina341
Medico Quirurgicos
#29
MEDLINE INDUSRIES INCUnited States340
Medico Quirurgicos
#30
VIRCHOW BIOTECH PVT LTD UNIT IIIndia340
Medico Quirurgicos
#31
HANGZHOU DTC MEDICAL APPARATUS CO., LTDChina329
Medico Quirurgicos
#32
MAXTER GLOVE MANUFACTURING SDN BHDMalaysia325
Medico Quirurgicos
#33
ANHUI INTCO MEDICAL PRODUCTS CO., LTDChina324
Medico Quirurgicos
#34
PROMEGA CORPORATIONUnited States320
In Vitro Reagents
Reactivo Diagnostico
#35
JIANERKANG MEDICAL CO., LTD.China318
Medico Quirurgicos
#36
A1 GLOBE SDN BHDMalaysia317
Medico Quirurgicos
#37
MAXWELL GLOVE MANUFACTURING BERHADMalaysia316
Medico Quirurgicos
#38
TIB MOLBIOL SYNTHESELABOR GMBHGermany316
In Vitro Reagents
Reactivo Diagnostico
#39
JIUJIANG HUADA MEDICAL DRESSING CO., LTDChina288
Medico Quirurgicos
#40
ZHENDE MEDICAL CO., LTDChina285
Medico Quirurgicos
#41
SRI TRANG GLOVES (THAILAN) CO. LTDThailand284
Medico Quirurgicos
#42
INDUSTRIAS SAN FIORANO S.A.S / SIGLA: SANFIORANOColombia279
Medico Quirurgicos
#43
TOP GLOVE SDN BHDMalaysia275
Medico Quirurgicos
#44
HUBEI QIANJIANG KINGPHAR MEDICAL MATERIAL CO., LTDChina274
Medico Quirurgicos
#45
AFFYMETRIX PTE LTDSingapore266
In Vitro Reagents
#46
BLUE SAIL MEDICAL CO., LTDChina259
Medico Quirurgicos
#47
HUBEI ZHONGJIAN MEDICAL PRODUCTS CO., LTD.China258
Medico Quirurgicos
#48
MEDWELL MEDICAL PRODUCTS CO., LTDChina258
Medico Quirurgicos
#49
HAIAN MEDIGAUZE CO., LTDChina257
Medico Quirurgicos
#50
TG MEDICAL SDN BHDMalaysia257
Medico Quirurgicos

Top 50 Registration Holders in Colombia

Published registration holder names ranked by active registrations held. Foreign manufacturers register through a Colombia Registration Holder (CRH) that owns the INVIMA registration.

RankRegistration HolderRegistrationsManufacturers represented
#1
ALFA TRADING S.A.S.15,11160
#2
LIFE TECHNOLOGIES CORPORATION12,34315
#3
LABORATORIOS HIGIETEX S.A.S.10,6496
#4
MEDLINE INDUSTRIES, LP8,57871
#5
4 GASA, S.L.6,04811
#6
ALFA TRADING S.A.S4,46460
#7
PLACECOL S.A4,3906
#8
JOHNSON & JOHNSON MEDTECH COLOMBIA S.A.S.3,657179
#9
ABBOTT LABORATORIES DE COLOMBIA S.A.S.3,656114
#10
THERMO FISHER SCIENTIFIC COLOMBIA S.A.S.3,58644
#11
IVOCLAR VIVADENT AG3,37610
#12
ANNAR DIAGNOSTICA IMPORT S.A.S.3,050154
#13
HOYA OPTICAL LABS OF AMERICA, INC.2,62029
#14
BOSTON SCIENTIFIC CORPORATION2,58282
#15
BECTON DICKINSON DE COLOMBIA LTDA2,497110
#16
MERIT MEDICAL COLOMBIA S.A.S.2,05032
#17
WELCH ALLYN INC1,9555
#18
MEDTRONIC INC1,689156
#19
KCI COLOMBIA S.A.S1,60340
#20
BSN MEDICAL LTDA1,58225
#21
ROCHE DIAGNOSTICS GMBH1,57743
#22
SANITAS S.A.S1,57122
#23
THERMO FISHER SCIENTIFIC COLOMBIA S.A.S1,54815
#24
ROCHEM BIOCARE COLOMBIA S.A.S.1,53550
#25
SIEMENS HEALTHCARE S.A.S1,50369
#26
ANNAR DIAGNOSTICA IMPORT S.A.S1,50193
#27
AM ASESORIA Y MANTENIMIENTO LTDA1,4858
#28
MINDRAY MEDICAL COLOMBIA S.A.S.1,42523
#29
ALFA TRADING SAS1,34412
#30
QUIMIOLAB S.A.S1,27968
#31
ILLUMINA COLOMBIA S.A.S.1,2637
#32
NIPRO MEDICAL CORPORATION1,210109
#33
COMERCIALIZADORA Y DISTRIBUIDORA 714 SEVEN ONE FOUR S.A.S1,21019
#34
ALPHA BIO TEC LTD1,16111
#35
ULTRADENT PRODUCTS INC1,0885
#36
INVERSIONES DDHO S.A.S1,08212
#37
MEDTRONIC INC.1,03489
#38
LA MUELA S.A.S1,03422
#39
BECKMAN COULTER COLOMBIA S.A.S.1,03052
#40
LABCARE DE COLOMBIA S.A.S1,00260
#41
COOPERVISION INC9928
#42
PROCTER & GAMBLE COLOMBIA LTDA96247
#43
DENTSPLY FINANCE CO.96029
#44
BECKMAN COULTER COLOMBIA S.A.S94336
#45
KCI COLOMBIA SAS87528
#46
TIB MOLBIOL SYNTHESELABOR GMBH8631
#47
BIOSCIENCES SAS81633
#48
CARDINAL HEALTH 200 LLC77142
#49
MACCURA BIOTECHNOLOGY CO., LTD7591
#50
ILLUMINA COLOMBIA S.A.S7577
About the data

What the INVIMA medical device registry shows

The Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) regulates medical devices in Colombia. As of 2026-08-20, this official dataset snapshot contains 390,583 registration records, of which 266,115 are currently active and 124,468 are cancelled, expired, or withdrawn. The most frequently listed manufacturer name is US COTTON MÉXICO S. DE R.L. DE C.V. with 2,417 registrations. China is the most represented manufacturer country, accounting for 20,394 active registrations (7.7%). The dataset lists 4,038 distinct published registration holder names.

Every figure is computed from the official dataset snapshot as mirrored in the Pure Global database — “active” excludes cancelled, expired, and withdrawn records. 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 Colombia device database, or see our methodology for how the data is collected.

VerifiedInstituto Nacional de Vigilancia de Medicamentos y Alimentos · 390,583 records · generated 2026-08-26
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