HomeIndiaMeril Healthcare Private Limited

Meril Healthcare Private Limited

India · Vapi
✓ 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
6listed device types
Class I 0Class II 6Class III 0
plus 10 registration records and 25 510(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
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 States10 registration records, 25 510(k), 0 PMA, 5 excluded
Brazil3 confirmed, 10 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: MERIL HEALTHCARE PVT. LTD. · MERIL HEALTHCARE PVT, LTD.
Same-named companies — This database also contains companies with near-identical names: Meril Healthcare Pvt. , Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
India
City
Vapi

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12013
12015
32016
42017
42018
22019
12020
22021
12022
22023
32024
12025

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)

MarketIdentifierNameClass / date
USK252644PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture2025-09-23
USK233386Monik™ - Disposable Endoscopic Trocar2024-05-24
USK2322461) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture2024-04-25
BR10360810029KIT INSTRUMENTAL PARA QUADRILClass I
BR10360810022Kit Instrumental para JoelhoClass I
BR10360810084Kit Instrumental - Acesso Anterior Direto (DAA)Class I

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