HomeChinaHUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.

HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.

China · Xiangtan Hunan
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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
6listed device types
Class I 1Class II 5Class III 0
plus 18 registration records and 17 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class I 1Class II 2
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
6 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 States18 registration records, 17 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD. · HUNAN VATHIN MEDICAL INSTRUMENTS CO., LTD. · HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD · Hunan Vathin Medical Instrument Co., Ltd
Same-named companies — This database also contains companies with near-identical names: HUNAN VATHIN MEDICAL INSTRUMENTS CO., LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Xiangtan Hunan

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

12020
32022
32023
52024 · K242535
52025 · K250232

FDA listed device types

Nasopharyngoscope (Flexible Or Rigid) 1Bronchoscope (Flexible Or Rigid) 1Cystoscope And Accessories, Flexible/Rigid 1Endoscopic Access Overtube, Gastroenterology-Urology 1Ureteroscope And Accessories, Flexible/Rigid 1Accessories, Photographic, For Endoscope (Exclude Light Sources) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250232Vathin® Video Bronchoscope System2025-07-25
USK251599Single-use Ureteral Access Sheath2025-07-03
USK250785Single-use Flexible Ureteroscope2025-05-06
BR80102519206Ureteroscópio Flexível de Uso únicoClass II
BR80102513118Monitor digital de vídeo VathinClass I
BR80102519207Rinolaringoscópio Flexível de uso únicoClass II
SAME0000016796SFDAA00007Trolley (with pylon)
SAME0000016796SFDAA00009Digital Video Monitor

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