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Fortune Medical Instrument Corp.

Taiwan · New Taipei City · www.fortunemed.com

✓ Record-verifiedregistrations found in 11 marketsEU SRN CN-MF-000023028

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Singapore, South Korea, Australia, Hong Kong, Israel — 11 overseas markets. EU UDI-DI records ≥283, 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

≥283UDI-DI device records

Class I 83Class IIa 172Class IIb 28

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

USUnited StatesFDA openFDA

27listed device types

Class I 19Class II 8Class III 0

plus 31 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

18registered device records

Class I 4Class IIa 9Class IIb 5

BRBrazilANVISA

23registered devices

Class I 4Class II 19

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

15 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

5device registrations

CLASS B 3CLASS C 2

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

3active ARTG entries

Class I 2IIa 1

HKHong KongMDACS

2valid listings

Class II 1Class III 1

ILIsraelAMAR

2registrations

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 Union1,033 raw hits, 17 excluded, 283 confirmed. Large result set — only the first 300 verified

United States31 registration records, 6 510(k), 0 PMA, 8 excluded

United Kingdom18 confirmed, 3 excluded

Brazil23 confirmed, 2 excluded

Saudi Arabia2 confirmed, 1 excluded

Manufacturer names merged into this page: FORTUNE MEDICAL INSTRUMENT CORP. · FORTUNE MEDICAL INSTRUMENT CORP · Fortune Medical Instrument Corp

Regulatory identity

EU manufacturer SRN: CN-MF-000023028
EU authorised representative: SUNGO Europe B.V.
UK responsible person: Emergo Consulting (UK) Limited

FDA 510(k) clearances by year

21998 · K980917

22002 · K021142

22003 · K022112

FDA listed device types

showing 8 of 27

Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection 1Extractor, Vacuum, Fetal 1Tubes, Gastrointestinal (And Accessories) 1Catheter, Urological 1Catheter, Retention Type, Balloon 1Catheter, Suprapubic (And Accessories) 1Catheter, Urethral 1Gastrointestinal Tubes With Enteral Specific Connectors 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06980058103868	—	Class I
EU	06980058103851	—	Class I
EU	06980058103790	—	Class I
EU	06980058103455	—	Class I
UK	10696	Silicone T-Drainage Tube	Class IIa
UK	31667	Catheter Spigot	Class I
UK	45389	Endo Connector	Class I
US	K022112	FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020	2003-04-03
US	K021193	FORTUNE SILICONE VACUUM SUCTION, MODEL #1300	2003-02-12
US	K021142	ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865	2002-10-01
BR	10315890001	RESSUSCITADOR FORTUNE	Class II
BR	10315890003	MÁSCARA LARÍNGEA DE SILICONE	Class II
BR	10315890006	CÂNULA	Class I
SA	ME0000006805SFDAA00007	Rystora Silicone Scar Sheet	—
SA	ME0000006805SFDAA00008	Rystora Silicone Scar Gel	—

Fortune Medical Instrument Corp.

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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