HomeChinaSHANGHAI ISO MEDICAL PRODUCTS CO., LTD.

SHANGHAI ISO MEDICAL PRODUCTS CO., LTD.

China · Shanghai
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Australia, Hong Kong, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
8listed device types
Class I 6Class II 2Class III 0
plus 11 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
20registered devices
Class I 17Class II 3
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
8valid device licences
Class I 4Class II 4
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
Import 3
AUAustraliaTGA ARTG
12active ARTG entries
Class I 1IIa 2IIb 9
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 States11 registration records, 0 510(k), 0 PMA, 3 excluded
Brazil20 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: SHANGHAI ISO MEDICAL PRODUCTS CO., LTD. · SHANGHAI ISO MEDICAL PRODUCTS CO. LTD · Shanghai ISO Medical Products Co Ltd

Company information

Country
China
City
Shanghai

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 listed device types

Topical Approximation System 1Device, Intravascular Catheter Securement 1Dressing, Wound, Hydrophilic 1Tape And Bandage, Adhesive 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1Dressing, Wound, Occlusive 1Negative Pressure Wound Therapy Powered Suction Pump 1Drape, Surgical, Exempt 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80184189003BIO-AID HEMOClass II
BR82696710003Curativo filme transparente island BClass I
BR82696710005Curativo Filme Island CompostoClass I

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