Home›China›Shenzhen Vivolight Medical Device & Technology Co., Ltd.

Shenzhen Vivolight Medical Device & Technology Co., Ltd.

✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000012605

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia, Hong Kong, Israel, Russia — 10 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

9UDI-DI device records

Class I 9

USUnited StatesFDA openFDA

4listed device types

Class I 2Class II 2Class III 0

plus 3 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class I 1

BRBrazilANVISA

1registered devices

Class I 1

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

SASaudi ArabiaSFDA

2registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 4

HKHong KongMDACS

1valid listings

Class IV 1

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

4active registrations

Class 1 1Class 2a 1Class 2b 1Class 3 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.

European Union9 raw hits, 0 excluded, 9 confirmed

United States3 registration records, 1 510(k), 0 PMA

United Kingdom1 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: SHENZHEN VIVOLIGHT MEDICAL DEVICE&TECHNOLOGY CO., LTD. · SHENZHEN VIVOLIGHT MEDICAL DEVICE & TECHNOLOGY CO.,LTD. · Shenzhen Vivolight Medical Device & Technology Co.,Ltd.

Regulatory identity

EU manufacturer SRN: CN-MF-000012605
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: Etheria Medical Ltd

FDA 510(k) clearances by year

12025 · K242098

FDA listed device types

Catheter, Intravascular, Diagnostic 1System, Imaging, Optical Coherence Tomography (Oct) 1Device, Vein Location, Liquid Crystal 1Microscope, Surgical, General & Plastic Surgery 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06971141530609	VEINCAS	Class I
EU	06971141530616	VEINCAS	Class I
EU	06971141530098	VEINCAS	Class I
EU	06971141530043	VEINCAS	Class I
UK	48040	Projection Vein Finder	Class I
US	K242098	Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)	2025-04-11
BR	82176160012	Veincas	Class I
SA	ME0000009584SFDAA00001	VIVOLIGHT	—
SA	ME0000009584SFDAA00002	VIVOLIGHT	—

Shenzhen Vivolight Medical Device & Technology Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies