HomeChinaSTAR SPORTS MEDICINE CO., LTD.

STAR SPORTS MEDICINE CO., LTD.

China · Beijing
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Australia, Israel, Russia — 8 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
36listed device types
Class I 30Class II 4Class III 0unclassified 2
plus 50 registration records and 22 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
83registered devices
Class I 56Class II 27
100 including historic records
SASaudi ArabiaSFDA
36registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
44active device licences
Class II 1Class III 43
315 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS D 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
16active ARTG entries
Class I 2IIa 4IIb 10
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
1active registrations
Class 2b 1
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 States50 registration records, 22 510(k), 0 PMA, 43 excluded
Brazil83 confirmed, 11 excluded
Saudi Arabia36 confirmed, 2 excluded
Canada44 confirmed, 2 excluded
Manufacturer names merged into this page: MUELLER SPORTS MEDICINE, INC. · Zhejiang Steriger Sports Medicine Technology Co.,Ltd · ROG SPORTS MEDICINE, INC. · STAR SPORTS MEDICINE CO., LTD. · BIOMET ORTHOPEDICS, ATA BIOMET SPORTS MEDICINE, ATA BIOMET BIOLOGICS, ATA BIOMET TRAUMA · BIOMET SPORTS MEDICINE, INC.

Company information

Country
China
City
Beijing

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

11990
11995
42007
12008
12010
92011
22013
12014
12016
12017

FDA listed device types

showing 8 of 36
Orthosis, Lumbar 1Splint, Hand, And Components 1Support, Scrotal, Therapeutic 1Orthosis, Limb Brace 1Splint, Intranasal Septal 1Bag, Ice 1Orthosis, Truncal/Orthosis, Limb 1Pack, Hot Or Cold, Reusable 1

Registration details (sample)

MarketIdentifierNameClass / date
USK170364Collagen Meniscus Implant XL2017-05-02
USK153087IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved2016-07-14
USK140908JUGGERKNOT MINI SOFT ANCHOR2014-10-02
BR80991389057INSTRUMENTAIS ESTÉREIS STARClass II
BR80991389058INSTRUMENTAIS STARClass II
BR80991389059KIT DE ARTROSCOPIA STARClass II
SAME0000001909SFDAA00091Guide Wire
SAME0000007364SFDAA00002KNOT PUSHER
CA1012ASCENT KNEE PROSTHESISClass III
CA3083REPICCI II UNICONDYLAR KNEEClass III
CA11838AGC MOLDED TIBIAL COMPONENTClass III

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