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SHANGHAI ELECTRICAL APPARATUS IMP.& EXP. CO., LTD.

China · Shanghai

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 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

370listed device types

Class I 324Class II 40Class III 0unclassified 6

plus 593 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

201registered devices

Class I 114Class II 87

269 including historic records

SASaudi ArabiaSFDA

23registered 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 States593 registration records, 4 510(k), 0 PMA, 1 excluded

Brazil201 confirmed, 0 excluded

Saudi Arabia23 confirmed, 0 excluded

Manufacturer names merged into this page: Wenzhou Kenbo IMP. & EXP. CO.,Ltd · SUZHOU HENGXIANG IMP. & EXP. CO., LTD · SHANGHAI MEDICINES & HEALTH PRODUCTS IMP. & EXP. CO., LTD. · NINGBO CHIBANDA IMP &EXP CO, LTD · HEMAGEN DIAGNÓSTICOS COM IMP EXP LTDA · TRAUMEC TECNOLOGIA E IMPLANTES ORTOPÉDICOS IMP. E EXP. LTDA - EPP

FDA 510(k) clearances by year

11996 · K955918

12002 · K022299

12012 · K120004

12024 · K240810

FDA listed device types

showing 8 of 370

Pad, Eye 1Syringe, Restorative And Impression Material 1Solvent, Adhesive Tape 1Armrest, Wheelchair 1Knife, Nasal 1Radiographic Protective Glove 1Instrument, Contouring, Matrix, Operative 1Drill, Dental, Intraoral 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240810	Anti Grinding Guard	2024-05-24
US	K120004	(MULTIPLE) DIGITAL THERMOMETER	2012-08-23
US	K022299	TRILUX, Z-TONE, ACRY ROCK	2002-10-07
BR	10280220138	ANTICORPO ENDOMISIAL IgA (EmA ) IMUNOFLUORESCENCIA VIRGO	Class II
BR	10322610031	ANTICORPO CITOPLASMATICO ANTI-NEUTROFILO(PANCA) EIA	Class II
BR	80455630119	Distrator Osteogênico Extraoral Bidirecional Traumec	Class I
SA	ME0000010144SFDAA00005	Non sterile gauze swab	—
SA	ME0000010144SFDAA00002	Gauze Lap Sponge	—

SHANGHAI ELECTRICAL APPARATUS IMP.& EXP. CO., LTD.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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