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Pollogen, Ltd.

Israel · Tel Aviv

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel, Russia — 7 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

6listed device types

Class I 2Class II 4Class III 0

plus 15 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

7active device licences

Class II 2Class III 5

15 including historic records

TWTaiwanTFDA

6valid device licences

Class II 6

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

8active ARTG entries

IIa 4IIb 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

10registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 2Class 2b 2

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 States15 registration records, 18 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: POLLOGEN LTD · POLLOGEN LTD. · POLLOGEN, LTD

Business registration

Legal name: POLLOGEN LTD
Company number: 513846626
Registration status: Active
Incorporated: 2006-06-22

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

FDA 510(k) clearances by year

12011

22013

12014

12017

12018

12019

22021

12022

22023

32024

32025

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Massager, Vacuum, Radio Frequency Induced Heat 1Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction 1Stimulator, Muscle, Powered, For Muscle Conditioning 1Brush, Dermabrasion, Powered 1Massager, Therapeutic, Electric 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242227	GENEO X ELITE	2025-10-12
US	K252576	Legend X Platform	2025-09-12
US	K250734	OptiLUV Device	2025-09-10
BR	81987069014	Legend Pro+	Class II
BR	81987069015	triLift	Class II
CA	78584	APOLLO TRIPOLLAR RF SYSTEM	Class III
CA	81252	TOPJEN MIDI SKIN TIGHTENING SYSTEM	Class III
CA	81253	TOPJEN MAXI SKIN TIGHTENING SYSTEM	Class III

Pollogen, Ltd.

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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