HomeChinaSHANGHAI MEKON MEDICAL DEVICES CO., LTD.

SHANGHAI MEKON MEDICAL DEVICES CO., LTD.

China · Shanghai
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
11listed device types
Class I 2Class II 9Class III 0
plus 10 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
17registered devices
Class I 1Class II 16
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
1active device licences
Class II 1
10 including historic records
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 States10 registration records, 0 510(k), 0 PMA
Brazil17 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: SHANGHAI MEKON MEDICAL DEVICES CO., LTD. · SHANGHAI MEKON MEDICAL DEVICES CO., LTD · SHANGAI MEKON MEDICAL DEVICE CO. LTD.
Same-named companies — This database also contains companies with near-identical names: SHANGAI MEKON MEDICAL DEVICE CO. LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

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

showing 8 of 11
Low Dead Space Needle, Single Lumen, Hypodermic 1Ophthalmic Needle 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1Low Dead Space Piston Syringe 1Syringe, Piston 1Set, Administration, Intravascular 1Needle, Hypodermic, Single Lumen 1Ophthalmic Syringe 1

Registration details (sample)

MarketIdentifierNameClass / date
BR81382050007Smart Micro CânulaClass I
BR81431619024Cânula Pain Free Articular ou Extra-articular - MOREClass II
BR81431619003Agulha de Punção Articular ou Extra-articular MekonClass II
CA110476SYRINGEClass II

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