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Advantech

✓ Record-verifiedregistrations found in 5 marketsEU SRN TW-MF-000029374Unified social credit code 91110108625905678U

This company has registrations in European Union, United States, United Kingdom, Saudi Arabia, South Korea — 5 overseas markets. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

0China registrations

as of 2026-09-01

EUEuropean UnionEUDAMED

27UDI-DI device records

Class I 27

USUnited StatesFDA openFDA

7listed device types

Class I 0Class II 7Class III 0

plus 5 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

12registered device records

Class I 12

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered 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

2GMP quality-system certificates

Import 2

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.

European Union27 raw hits, 0 excluded, 27 confirmed

United States5 registration records, 3 510(k), 0 PMA, 1 excluded

China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01

United Kingdom12 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: ADVANTECH CORPORATION · Advantech Co. Ltd.

Regulatory identity

EU manufacturer SRN: TW-MF-000029374
EU authorised representative: Emergo Europe B.V.
UK responsible person: Emergo Consulting (UK) Limited
Unified social credit code: 91110108625905678U
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 1994-04-25
Registered capital: USD 4,230,000
Paid-in capital: USD 4,230,000
Legal form: Limited liability company (wholly owned by a HK/Macao/Taiwan corporation)
Industry classification: Computer, communications and other electronic equipment
Last approval date: 2025-01-02

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

31990 · K904182

FDA listed device types

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days 1System, Image Processing, Radiological 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1Endoscopic Central Control Unit 1Cerebral Oximeter 1Oximeter, Tissue Saturation 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04719879820409	Intelligent Power System	Class I
EU	04719896047063	Computer	Class I
EU	04719896015574	Computer	Class I
EU	04719896000594	Computer	Class I
UK	36502	Advantech Computer	Class I
UK	36502	Advantech	Class I
UK	36612	Advantech	Class I
US	K904182	R-800-SF	1990-11-13
US	K900007	R-100-ET MANUAL COLLIMATOR	1990-02-06
US	K896486	R-150-ET COLLIMATOR	1990-01-23
SA	ME0000003156SFDAA00006	Advantech Mobile Intelligent System	—
SA	ME0000003156SFDAA00006	Advantech Mobile Intelligent System	—

Advantech

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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