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Shanghai Bolan Optical-Electric 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

1listed device types

Class I 0Class II 1Class III 0

plus 1 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 4

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

SASaudi ArabiaSFDA

1registered 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 States1 registration records, 1 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: SHANGHAI BOLAN OPTICAL ELECTRIC CO., LTD · SHANGAI BOLAN OPTICAL-ELETRIC CO, LTD · Shanghai Bolan Optical-electric Co.,ltd · Shanghai Bolan Optical-Electric Co., Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
US	K153545	Portable Slit Lamp	2016-06-22
BR	80310280006	LAMPADA DE FENDA VISION COM MESA ELETRICA E TONOMETRO	Class I
BR	80011400016	Lâmpada de Fenda	Class I
BR	80310289001	PUPILOMETRO DIGITAL VISION	Class I
SA	ME0000003524SFDAA00001	Slit Lamp Microscope	—

Shanghai Bolan Optical-Electric 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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