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SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED

India · Kadi Gujar?T

✓ 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

60listed device types

Class I 40Class II 19Class III 0unclassified 1

plus 117 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 7Class II 1

10 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 States117 registration records, 20 510(k), 0 PMA, 1 excluded

Brazil8 confirmed, 0 excluded

Manufacturer names merged into this page: SOLCO BIOMEDICAL CORP. · SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED · SOLCO BIOMEDICAL CO., LTD. · SOLCO BIOMEDICAL CO. LTD. · SOLCO BIOMEDICAL CO LTD

FDA 510(k) clearances by year

32005

12006

22008

12010

22011

12012

12017

42019

12021

22022

22024

FDA listed device types

showing 8 of 60

Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Screw, Fixation, Bone 1Washer, Bolt Nut 1Intervertebral Fusion Device With Integrated Fixation, Cervical 1Appliance, Fixation, Spinal Interlaminal 1Cement, Bone, Vertebroplasty 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231655	4CIS® Chiron Spinal Fixation System	2024-11-26
US	K232607	4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM	2024-02-27
US	K213653	4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM	2022-12-19
BR	80991380099	Instrumentais para coluna Solco	Class I
BR	10444710018	Instrumentais para Sistema de Implantes CAGE PEEK	Class I
BR	10444710020	Instrumentais para Sistema de Implantes CAGE ONE TOUCH	Class I

SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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