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Meril Healthcare Pvt. , Ltd.

India · Vapi Gujar?T

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 9 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

6listed device types

Class I 0Class II 6Class III 0

plus 10 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 3

8 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

4valid device licences

Class I 1Class II 3

SGSingaporeHSA SMDR

4device registrations

CLASS C 4

KRSouth KoreaMFDS GMP

6GMP quality-system certificates

Import 6

AUAustraliaTGA ARTG

26active ARTG entries

Class I 1Class III 20IIb 5

HKHong KongMDACS

3valid listings

Class III 3

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

3active registrations

Class 1 1Class 2b 1Class 3 1

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 States10 registration records, 8 510(k), 0 PMA, 8 excluded

Brazil3 confirmed, 10 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: MERIL HEALTHCARE PVT. LTD. · MERIL HEALTHCARE PVT, LTD.

FDA 510(k) clearances by year

12016

12017

22018

12019

12021

12022

12023

FDA listed device types

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented 1Plate, Fixation, Bone 1Screw, Fixation, Bone 1Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented 1Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K222436	Latitud Hip Replacement System	2023-05-09
US	K222816	Opulent TiNbN Coated Knee	2022-11-18
US	K212839	Opulent TiNbN Coated Knee	2021-11-16
BR	10360810029	KIT INSTRUMENTAL PARA QUADRIL	Class I
BR	10360810022	Kit Instrumental para Joelho	Class I
BR	10360810084	Kit Instrumental - Acesso Anterior Direto (DAA)	Class I