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LABORATORIOS SL SA

Argentina · Malvinas Argentinas Buenos Aires

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 1Class II 6Class III 0

plus 3 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

39registered devices

Class I 18Class II 21

50 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States3 registration records, 0 510(k), 0 PMA, 40 excluded

Brazil39 confirmed, 12 excluded

Saudi Arabia0 confirmed, 10 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: LABORATORIOS SL SA · LABORATORIOS SL S.A. · LABORATORIOS SL S.A · lABORATÓRIOS SL S.A

FDA listed device types

Template 1Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented 1Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented 1Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented 1Prosthesis, Hip, Hemi-, Femoral, Metal 1Cement, Bone, Vertebroplasty 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80802410003	SUBIMIX V	Class II
BR	80802419001	SUBTON BOWL	Class I
BR	80802410004	SUBITON VTP CÂNULA DE PUNÇÃO DE CORPO VERTEBRAL PARA VERTEBROPLASTIA E	Class II

LABORATORIOS SL SA

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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