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DONGGUAN ACE-TEC CO., LTD.

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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 6 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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.

United States6 registration records, 1 510(k), 0 PMA, 19 excluded

Brazil2 confirmed, 11 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Guangdong Ace-Tec Co., Ltd. · DONGGUAN ACE-TEC CO., LTD. · ACE-TEC CO.,LIMITED

Same-named companies — This database also contains companies with near-identical names: ACE-TEC CO.,LIMITED, Guangdong Ace-Tec Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12025 · K252994

FDA listed device types

Toothbrush, Powered 1Massager, Therapeutic, Electric 1Stimulator, Transcutaneous Electrical, Aesthetic Purposes 1Light Based Over The Counter Wrinkle Reduction 1Stimulator, Muscle, Powered, For Muscle Conditioning 1Over-The-Counter Powered Light Based Laser For Acne 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252994	LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)	2025-12-08
BR	80520090004	I-ACNE	Class II
BR	80026839002	MASSAGEADOR ANTI CELULITE	Class I

DONGGUAN ACE-TEC 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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