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Mediplus (India) Limited

India · New Delhi · www.mediplusindialtd.com

✓ Record-verifiedregistrations found in 4 marketsEU SRN IN-MF-000007279

This company has registrations in European Union, United States, United Kingdom, Brazil — 4 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

11UDI-DI device records

Class IIa 11

USUnited StatesFDA openFDA

1listed device types

Class I 0Class II 1Class III 0

plus 1 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

13registered device records

Class I 1Class IIa 10Class IIb 2

BRBrazilANVISA

72registered devices

Class I 13Class II 59

this export covers Class I / II only (the cadastro route)

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.

European Union13 raw hits, 2 excluded, 11 confirmed

United States1 registration records, 1 510(k), 0 PMA, 2 excluded

United Kingdom13 confirmed, 1 excluded

Brazil72 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: MEDIPLUS (INDIA) LIMITED · MEDIPLUS (INDIA) LIMITED (UNIT 2) · MEDIPLUS (INDIA) LTD

Regulatory identity

EU manufacturer SRN: IN-MF-000007279
EU authorised representative: mdi Europa GmbH

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08906025307624	TipSafe2	Class IIa
EU	08906025307631	TipSafe2	Class IIa
EU	08906025307655	TipSafe2	Class IIa
EU	08906025307662	TipSafe2	Class IIa
UK	58977	Multi Port TIVA sets PVC	Class IIa
UK	62179	Capnomask™	Class IIa
UK	35833	Multiple Infusion TIVA sets, PVC	Class IIa
US	K210037	Pluski Safe 1 Safety IV Catheter	2022-03-25
BR	80495519034	MEDIX BRASIL CATETER INTRAVENOSO COM DISPOSITIVO DE SEGURANÇA	Class II
BR	80495519037	MEDIX BRASIL TORNEIRA 3 VIAS	Class II
BR	80695710033	BIODESC - BOLSA COLETORA DE URINA	Class I

Mediplus (India) Limited

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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