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SMB CORPORATION OF INDIA

India · Mumbai Maharashtra · www.smbcorpn.com

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, United Kingdom, Brazil, Canada, Australia — 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

0UDI-DI device records

USUnited StatesFDA openFDA

10listed device types

Class I 7Class II 3Class III 0

plus 9 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

15registered device records

Class I 9Class IIa 1Class III 5

BRBrazilANVISA

2registered devices

Class I 2

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

7 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class Is (sterile) 5

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 Union1,272 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States9 registration records, 1 510(k), 0 PMA, 1 excluded

United Kingdom15 confirmed, 0 excluded

Brazil2 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: SMB CORPORATION OF INDIA · SMB MEDICAL DEVICES PVT. LTD. (DOING BUSINESS AS SMB CORPORATION OF INDIA)

Regulatory identity

UK responsible person: CMC Medical Devices LTD

FDA 510(k) clearances by year

12024 · K231558

FDA listed device types

showing 8 of 10

Sound, Uterine 1Amniotome 1Forceps 1Scissors, Medical, Disposable 1Forceps, General & Plastic Surgery 1Remover, Intrauterine Device, Contraceptive, Hook-Type 1Dilator, Cervical, Fixed Size 1Needle, Hypodermic, Single Lumen 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	12990	Amniotomy Hook (Amniotic Membrane Perforator)	Class IIa
UK	11266	Vaginal / Cervical Dilator	Class I
UK	61480	IUD Thread Retriever	Class I
US	K231558	SMB Luer lock disposable syringe	2024-01-12
BR	80117580723	IUD Instruments (Polypropylene)	Class I
BR	80117580724	IUD Instruments (Polycarbonate)	Class I
CA	99851	SMB IUD INSERTION KIT	Class II

SMB CORPORATION OF INDIA

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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