Contact:haixiao@sungolytest.com+86 158 2169 5110 (WeChat)+86 132 4819 8029 Members 中文
Home›China›Weigao Orthopaedic Device Co., Ltd.

Weigao Orthopaedic Device Co., Ltd.

China · Shanghai
✓ 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
42listed device types
Class I 14Class II 28Class III 0
plus 66 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
15registered devices
Class I 8Class II 7
20 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
0valid device licences
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 States66 registration records, 7 510(k), 0 PMA, 5 excluded
Brazil15 confirmed, 10 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO.,LTD · SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO., LTD. · SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO., LTD
Same-named companies — This database also contains companies with near-identical names: Orthopaedic Device Corp.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Shanghai

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

12012 · K121312
32013 · K122994
12014 · K133053
12016 · K160320
12017 · K170861

FDA listed device types

showing 8 of 42
Electrosurgical, Cutting & Coagulation & Accessories 1Rod, Fixation, Intramedullary And Accessories 1Intervertebral Fusion Device With Bone Graft, Thoracic 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Posterior Metal/Polymer Spinal System, Fusion 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Electromyograph, Diagnostic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK170861Premier2017-08-04
USK160320Premier2016-04-01
USK133053MILESTONE SPINAL SYSTEM2014-07-15
BR81207910067Bomba para Distração Óssea WEGOClass I
BR81207919004Dispositivo para Distração Óssea WEGOClass II
BR81207910074Injetor de Cimento Ósseo WEGOClass I

Similar companies

Acoresmed Co., Ltd.
China · markets 1
Aimagine Care Technology Co., Ltd.
China · markets 2
Allmed Medical Products Co. Ltd.
China · markets 12
ALTON(shanghai)medical Instruments Co.,Ltd
China · markets 12
Ambulanc (Shenzhen) Tech. Co. Ltd.
China · markets 10
Andon Health Co., Ltd.
China · markets 10
Is this your company? Claim the page, add information or report a data error.Claim / report an error →