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Guangdong Newdermo Biotech Co., Ltd.

China · Panyu District Guangzhou

✓ Record-verifiedregistrations found in 4 markets

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

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

6listed device types

Class I 3Class II 3Class III 0

plus 5 registration records and 4 510(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

0active device licences

3 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States5 registration records, 4 510(k), 0 PMA

Manufacturer names merged into this page: Guangdong Newdermo Biotech Co., Ltd · GUANGDONG NEWDERMO BIOTECH CO., LTD

FDA 510(k) clearances by year

12023 · K223544

32026 · K261052

FDA listed device types

Brush, Dermabrasion, Powered 1Brush, Dermabrasion, Manual 1Pack, Hot Or Cold, Reusable 1Lamp, Infrared, Therapeutic Heating 1Light Based Over The Counter Wrinkle Reduction 1Over-The-Counter Powered Light Based Laser For Acne 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261052	LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)	2026-06-29
US	K260946	LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)	2026-06-18
US	K260202	LED Light Therapy Masks (LumiLips FAC07NA)	2026-03-23

Guangdong Newdermo Biotech 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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