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Shanghai Hua EN Industrial Co, Ltd.

China · Shanghai

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Australia — 4 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

49listed device types

Class I 46Class II 3Class III 0

plus 49 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

40registered 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

1active ARTG entries

Class I 1

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 States49 registration records, 2 510(k), 0 PMA, 7 excluded

Brazil2 confirmed, 1 excluded

Saudi Arabia40 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Shanghai Hua En Industrial Co Ltd · SHANGHAI HUA EN INDUSTRIAL CO., LTD · SHANGHAI HUA EN INDUSTRIAL CO LTD

FDA 510(k) clearances by year

22022 · K221838

FDA listed device types

showing 8 of 49

Cap, Surgical 1Gauze / Sponge,Nonresorbable For External Use 1Evacuator, Oral Cavity 1Syringe, Restorative And Impression Material 1Toothbrush, Manual 1Razor, Surgical 1Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter 1Syringe, Irrigating (Dental) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K221838	Surgical Face Mask (HNFM0103)	2022-08-17
US	K221222	Surgical Face Mask (HNFM0304)	2022-06-06
BR	80695719014	BIODESC - LANCETA DESCARTÁVEL	Class II
BR	80695710027	BIODESC - CATÉTER NASAL PARA OXIGÊNIO TIPO ÓCULOS	Class I
SA	ME0000008698SFDAA00001	isolation gown	—
SA	ME0000005855SFDAA00001	SAFETY GOGGLE	—

Shanghai Hua EN Industrial 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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