HomeIndiaSpm Medicare Pvt. , Ltd.

Spm Medicare Pvt. , Ltd.

India · Noida Uttar Pradesh
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Taiwan, Australia, Israel — 5 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
22listed device types
Class I 20Class II 2Class III 0
plus 22 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
10registered devices
Class I 1Class II 9
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
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 States22 registration records, 2 510(k), 0 PMA
Brazil10 confirmed, 0 excluded
Saudi Arabia0 confirmed, 1 excluded
Manufacturer names merged into this page: SPM MEDICARE PVT, LTD. · SPM MEDICARE PVT. LTD.

Company information

Country
India
City
Noida Uttar Pradesh

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

12023 · K231724
12024 · K233794

FDA listed device types

showing 8 of 22
Sling, Arm, Overhead Supported 1Orthosis, Foot Drop 1Arterial Blood Sampling Kit 1Support, Hernia 1Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Powered 1Garment, Protective, For Incontinence 1Finger Cot 1Binder, Abdominal 1

Registration details (sample)

MarketIdentifierNameClass / date
USK233794Insulin Syringe2024-03-06
USK231724Flush Syringe (Prefilled 0.9% normal saline solution)2023-11-09
BR81747150006FAMÍLIA SERINGA PARA COLETA DE SANGUE ARTERIAL IN-LINEClass I
BR81747159021CANULA INTRAVENOSA FECHADA COM ASA, COM EXTENSAO E DISPOSITIVO DE SEGUClass II
BR81747159022CANULA INTRAVENOSA COM DISPOSITIVO DE SEGURANCAClass II

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