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Shenzhen Kaiyan Medical Equipment Co., Ltd

China · Shenzhen · www.kaiyanmedical.com

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 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

0UDI-DI device records

USUnited StatesFDA openFDA

17listed device types

Class I 5Class II 12Class III 0

plus 53 registration records and 29 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

0registered devices

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

2active device licences

Class II 2

50 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

47active ARTG entries

Class I 2IIa 45

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.

European Union229 raw hits, 229 excluded, 0 confirmed

United States53 registration records, 29 510(k), 0 PMA

United Kingdom0 confirmed, 1 excluded

Brazil0 confirmed, 1 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: Shenzhen Kaiyan Medical Equipment Co., Ltd · SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.

FDA 510(k) clearances by year

42021

12022

22023

42024

112025 · K252414

72026 · K253932

FDA listed device types

showing 8 of 17

Light, Surgical, Floor Standing 1Light, Surgical, Ceiling Mounted 1Lamp, Infrared, Therapeutic Heating 1Stimulator, Transcutaneous Electrical, Aesthetic Purposes 1Heater, Perineal, Direct Contact 1Fat Reducing Low Level Laser 1Light Based Over The Counter Wrinkle Reduction 1Light, Surgical, Carrier 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253932	FACEGYM Pro Device (HD-109)	2026-07-23
US	K254025	LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)	2026-06-16
US	K260688	Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)	2026-05-04
CA	102932	PHOTOTHERAPY ACNE TREATMENT	Class II
CA	103008	PHOTOTHERAPY PANEL	Class II

Shenzhen Kaiyan Medical Equipment 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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