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CYDEN LIMITED

United Kingdom of Great Britain and Northern Ireland · Swansea

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, South Korea, Russia — 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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 21 registration records and 21 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

5active device licences

Class III 5

9 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2a 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.

United States21 registration records, 21 510(k), 0 PMA, 1 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: CYDEN LIMITED · CYDEN Ltd · CYDEN LTD

Business registration

Company number: 04470941
Registration status: Active
Legal form: Private Limited Company
Incorporated: 2002-06-26
Principal activity: 32500 - Manufacture of medical and dental instruments and supplies
Registered address: OFFICE BLOCK A BAY STUDIOS BUSINESS PARK, SWANSEA, SA1 8QB

Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12004

12005

22008

12009

12012

12013

22016

22017

32019

12020

12021

12022

22023

22024

FDA listed device types

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1Powered Laser Surgical Instrument 1Light Based Over-The-Counter Hair Removal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243362	SmoothSkin Pure Switch (SSC1)	2024-11-27
US	K240587	SmoothSkin Pure Unplugged (SSB3)	2024-03-29
US	K233782	SmoothSkin Pure Adapt (SSG3)	2023-12-20
CA	77059	IPULSE INTENSE PULSED LIGHT SYSTEMS	Class III
CA	77867	IPULSE I400 INTENSE PULSED LIGHT SYSTEM	Class III
CA	97844	VENUS SILK.EXPERT	Class III

CYDEN LIMITED

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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