HomeTaiwanPAONAN BIOTECH CO., LTD

PAONAN BIOTECH CO., LTD

Taiwan · Taipei
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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
21listed device types
Class I 12Class II 9Class III 0
plus 19 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
6registered devices
Class I 6
7 including historic records
SASaudi ArabiaSFDA
0registered 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
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 States19 registration records, 6 510(k), 0 PMA
Brazil6 confirmed, 0 excluded
Manufacturer names merged into this page: PAONAN BIOTECH CO., LTD · PAONAN BIOTECH CO., LTD · Paonan Biotech Co. Ltd · PAONAN BIOTECH LTD

Company information

Country
Taiwan
City
Taipei

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

12017 · K161225
12018 · K180226
32019 · K182285
12023 · K220261

FDA listed device types

showing 8 of 21
Instrument, Bending Or Contouring 1Screwdriver 1Template 1Wrench 1Probe 1Gauge, Depth 1Pusher, Socket 1Bender 1

Registration details (sample)

MarketIdentifierNameClass / date
USK220261NEST-C Interbody System2023-04-24
USK182285PK High Tibial Osteotomy Correction System2019-06-20
USK180230NEST Interbody System2019-01-25
BR81050760138Kit Instrumental para Cirurgia de Coluna PaonanClass I
BR80638410043FIXADOR EXTERNO PARA OSSOS MÉDIOS TRAUMAFIXClass I
BR80638410053FIXADOR EXTERNO PARA PUNHO EM PEEK ARTICULADOClass I

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