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Medical Device Registry Insights · ARCSA

Ecuador Medical Device Registry Statistics

Aggregated from 254,292 official ARCSA registration records. Data as of 2026-04-01.

228,202
Active registrations
1,192
Authorized Representative names
DJ Fang
DJ Fang
MedTech Regulatory Expert

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New registrations by year
201520162017201820192020202120222023202420252026
VerifiedARCSA · data as of 2026-04-01

Registrations by Product Type

Largest product type groups among active registrations

Product TypeRegistrationsShare
Invasivo141,93662.2%
Diagnostico In Vitro23,93810.5%
Activo18,7988.2%
[004] Diagnostico In Vitro14,9736.6%
No Invasivo13,1345.8%
[002] Invasivo12,2135.4%
[003] No Invasivo2,4381.1%
[001] Activo7580.3%

Top 50 Authorized Representatives in Ecuador

Published authorized representative names ranked by active registrations held.

RankAuthorized RepresentativeRegistrations
#1
TRAUMA ORTOPEDICS S. C. C.8,589
#2
ORTOPEDIA MEDICA ORMEDIC CIA. LTDA.8,175
#3
CREINECUADOR CIA. LTDA.6,755
#4
ZOLDAN CORPOREISHON COMPAÑIA RESPONSABILIDAD LIMITADA6,323
#5
DISORTHO INTERNACIONAL CIA. LTDA.6,285
#6
B.BRAUN MEDICAL S.A.5,548
#7
ULBAGAR CONSULTORIA Y REPRESENTACIONES CIA. LTDA.5,200
#8
SIMED S. A.5,051
#9
BENALCAZAR NEGRETE SANDRA PATRICIA4,166
#10
PESAN REPRESENTACIONES S.A.S.3,828
#11
DEPOSITO DENTAL NEO-TEC CIA. LTDA.3,664
#12
DEPOSITO DENTAL KROBALTO C.A.3,205
#13
CONSULTLMZ CIA. LTDA.3,197
#14
ALVAREZ LARREA EQUIPOS MEDICOS ALEM CIA. LTDA.3,032
#15
MEDICINA GLOBAL GLOMEDICAL CIA. LTDA.2,979
#16
CABAL CONSULTING CABALCONSULTORIA S.A.S.2,865
#17
ARG SPINE SYSTEMS REPRESENTACIONES CIA. LTDA.2,816
#18
INTERCENELI CIA. LTDA.2,700
#19
VIBAG C.A.2,608
#20
REGULATEC CIA. LTDA.2,606
#21
NORVENPRO S.A.2,342
#22
DYADENT CIA. LTDA.2,326
#23
BIOELECTRONICA BLANCO BLANCOSA S.A.2,302
#24
ROCHE ECUADOR S.A.2,189
#25
LAB QUALITY S.C.C.2,139
#26
MEDILABOR S.A.2,139
#27
DISORTEC DISTRIBUIDORA ORTOPEDICA DEL ECUADOR S A2,025
#28
DENTAL PEREZ AVILES CIA. LTDA.1,828
#29
SIPANCORPORATION SA1,809
#30
PINEDA CORAL JAIRO DARIO1,760
#31
MEDICA ECUADOR EQUIPOS E INSUMOS MEDICOS MEDECU C.A.1,698
#32
REPRESENTACIONES MEDICAS SG REMESIG S.A.1,684
#33
JOHNSON & JOHNSON (ECUADOR) S.A.1,649
#34
BANDA VANONI CIA. LTDA.1,631
#35
MEDAPTUS S.A.1,579
#36
VELARDE LOPEZ CHRISTIAN ANDRES1,536
#37
YARIKGROUP S.A.S.1,501
#38
REACTLAB IMPORT CIA. LTDA1,471
#39
NIPRO MEDICAL CORPORATION1,462
#40
ECUASURGICAL S.A.1,448
#41
INVIMEDIC S.A.1,396
#42
SISTEMAS DE SALUD ROCARSYSTEM S.A.1,308
#43
ABBOTT LABORATORIOS DEL ECUADOR CIA LTDA1,296
#44
SERVICIOS EMPLETEX S.A.1,267
#45
RECOR DENTAL Y QUIMEDIC CIA. LTDA1,242
#46
QUALITYDENTAL CIA.LTDA.1,203
#47
DICOSIM HRE CIA LTDA1,190
#48
PROTRAUMA S.A. PRODUCTOS TRAUMATOLOGICOS1,177
#49
VELASCO MURGUEITIO BYRON FERNANDO1,171
#50
DISTRIBUIDORA PRIMUSMEDICAL COMPAÑIA LIMITADA1,055
About the data

What the ARCSA medical device registry shows

The Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) regulates medical devices in Ecuador. As of 2026-04-01, this official dataset snapshot contains 254,292 registration records, of which 228,202 are currently active and 26,090 are cancelled, expired, or withdrawn. The dataset lists 1,192 distinct published authorized representative 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 Ecuador device database, or see our methodology for how the data is collected.

VerifiedAgencia Nacional de Regulación, Control y Vigilancia Sanitaria · 254,292 records · generated 2026-08-26
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