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Intersurgical Medical Sdn. Bhd.

Malaysia · Simpang Ampat Pulau Pinang

✓ 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

15listed device types

Class I 10Class II 5Class III 0

plus 20 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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.

United States20 registration records, 0 510(k), 0 PMA, 8 excluded

Brazil1 confirmed, 3 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: INTERSURGICAL MEDICAL APPARATUS (CHANGZHOU) CO., LTD. · Intersurgical Medical Sdn. Bhd. · INTERSURGICAL MEDICAL APPARATUS (CHANGZHOU) CO., LTD

Same-named companies — This database also contains companies with near-identical names: INTERSURGICAL MEDICAL APPARATUS (CHANGZHOU) CO., LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA listed device types

showing 8 of 15

Mask, Oxygen, Low Concentration, Venturi 1Mouthpiece, Breathing 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Mask, Oxygen, Non-Rebreathing 1Connector, Airway (Extension) 1Cannula, Nasal, Oxygen 1Mask, Oxygen 1Clip, Nose 1

Intersurgical Medical Sdn. Bhd.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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