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Acare Technology Co., Ltd.

✓ Record-verifiedregistrations found in 7 marketsEU SRN TW-MF-000031298

This company has registrations in European Union, United States, Brazil, Canada, South Korea, Australia, Israel — 7 overseas markets. EU UDI-DI records ≥104, the first 300 verified individually. 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

≥104UDI-DI device records

Class I 51Class IIa 31Class IIb 22

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

11listed device types

Class I 6Class II 5Class III 0

plus 15 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

3registered devices

Class I 2Class 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

23 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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.

European Union4,185 raw hits, 196 excluded, 104 confirmed. Large result set — only the first 300 verified

United States15 registration records, 2 510(k), 0 PMA

United Kingdom0 confirmed, 19 excluded

Brazil3 confirmed, 1 excluded

Saudi Arabia0 confirmed, 1 excluded

Manufacturer names merged into this page: ACARE TECHNOLOGY CO., LTD. · Acare Technology Co., Ltd.

Regulatory identity

EU manufacturer SRN: TW-MF-000031298
EU authorised representative: Surpass Biomedical Europe B.V.
Exhibition record: CMEF 89th (Apr 2024, Shanghai)

FDA 510(k) clearances by year

12011 · K111617

12019 · K182950

FDA listed device types

showing 8 of 11

Apparatus, Suction, Ward Use, Portable, Ac-Powered 1Regulator, Vacuum 1Bottle, Collection, Vacuum 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1Oximeter 1Strap, Head, Gas Mask 1Non-Surgical Gown 1Regulator, Pressure, Gas Cylinder 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04719872740049	Pulse Oximeter	Class IIb
EU	04719872744450	Inlet Adapter	Class I
EU	04719872747451	Inlet Adapter	Class I
EU	04719872749998	Inlet Adapter	Class I
US	K182950	Acare Suction Unit	2019-08-23
US	K111617	PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1	2011-12-22
BR	10349590129	MÁSCARA NASAL REUTILIZÁVEL EM SILICONE	Class II
BR	80626510017	regulador de aspiração bhp	Class I
BR	10349590123	MÁSCARA FACIAL REUTILIZÁVEL CPAP/BIPAP ACARE	Class I

Acare Technology Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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