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Home›China›YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHOLOGY CO, LTD.

YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHOLOGY CO, LTD.

China · Yangzhou
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. 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
pendingnot queried
USUnited StatesFDA openFDA
22listed device types
Class I 11Class II 11Class III 0
plus 33 registration records and 8 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
19registered devices
Class I 7Class II 12
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
12 including historic records
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 States33 registration records, 8 510(k), 0 PMA
Brazil19 confirmed, 0 excluded
Manufacturer names merged into this page: YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD · Yangzhou Fartley Medical Instrument Technology Co., Ltd · YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHOLOGY CO, LTD. · YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO. LTD.
Same-named companies — This database also contains companies with near-identical names: Yangzhou Fartley Medical Instrument Technology Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Yangzhou

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

52022 · K222980
12023 · K230004
12025 · K250732
12026 · K260423

FDA listed device types

showing 8 of 22
Tubing/Tubing With Filter, Insufflation, Laparoscopic 1Forceps, Biopsy, Non-Electric 1Accessories, Cleaning Brushes, For Endoscope 1Lubricant, Patient 1Endoscopic Bite Block 1Snare, Non-Electrical 1Cleaner, Ultrasonic, Medical Instrument 1Holder, Camera, Surgical 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260423Disposable Endoscopic Distal Attachments2026-05-28
USK250732Disposable Endoscopy Valve Set2025-06-20
USK230004Disposable Hemoclip2023-07-31
BR82214249009Agulha de Injeção de Endoscópio Descartável LynxClass II
BR82214249010Laço de Polipectomia à Frio Descartável LynxClass II
BR82214249011Pinça de apreensão descartável LynxClass II

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