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Ace Medical Co., Ltd

Korea, Republic · Seoul · www.ace-medical.com

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, United Kingdom, Brazil, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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

0UDI-DI device records

USUnited StatesFDA openFDA

15listed device types

Class I 9Class II 6Class III 0

plus 16 registration records and 36 510(k)

UKUnited KingdomMHRA PARD

14registered device records

Class I 2Class IIa 4Class IIb 8

BRBrazilANVISA

50registered devices

Class I 4Class II 46

52 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

5valid device licences

Class I 2Class II 3

SGSingaporeHSA SMDR

2device registrations

CLASS B 1CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

IIa 2IIb 2

HKHong KongMDACS

2valid listings

Class III 2

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 1Class 2b 3

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 Union7,943 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States16 registration records, 36 510(k), 0 PMA, 11 excluded

United Kingdom14 confirmed, 97 excluded

Brazil50 confirmed, 4 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: ACE MEDICAL DEVICES PVT. LTD · ACE MEDICAL INDUSTRy CO., LTD. · PT ACE MEDICAL PRODUCTS INDONESIA · ACE MEDICAL · ACE MEDICAL CO. LTD. · ACE KOREA MEDICAL CO.

Regulatory identity

UK responsible person: Emergo Consulting (UK) Limited

FDA 510(k) clearances by year

31987

11988

11989

21990

51991

11993

21994

31995

21996

31997

61998

21999

12006

12009

12016

12020

12025

FDA listed device types

showing 8 of 15

Pad, Menstrual, Unscented 1Fiber, Medical, Absorbent 1Bandage, Elastic 1Needle, Aspiration And Injection, Disposable 1Evacuator, Bladder, Manually Operated 1Dressing, Wound, Hydrophilic 1Tape And Bandage, Adhesive 1Gauze / Sponge,Nonresorbable For External Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	61514	AutoMed 3300	Class IIb
UK	47616	AutoMer II	Class IIb
UK	47618	AutoMer Set II	Class IIa
US	K242741	ACE Cannula	2025-01-08
US	K200387	Ace Medical Surgical Instruments	2020-07-21
US	K153055	ACE Electrosurgical Resection and Vaporization Electrodes Series	2016-07-11
BR	80299880069	AutoFuser PCA	Class II
BR	80299889029	AutoSelector K - Cânula para Infusão	Class II
BR	80299880140	AutoSelector - Cânula para Infusão	Class II