HomeChinaDOUBLE WHITE MEDICAL TECHNOLOGY DEVELOPMENT(GUANGZHOU) CO. LTD.

DOUBLE WHITE MEDICAL TECHNOLOGY DEVELOPMENT(GUANGZHOU) CO. LTD.

China · Guangzhou Guangdong
✓ 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
17listed device types
Class I 5Class II 12Class III 0
plus 20 registration records and 12 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
50registered devices
Class I 34Class II 16
67 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 States20 registration records, 12 510(k), 0 PMA, 7 excluded
Brazil50 confirmed, 3 excluded
Saudi Arabia0 confirmed, 3 excluded
Manufacturer names merged into this page: DOUBLE WHITE MEDICAL TECHNOLOGY DEVELOPMENT(GUANGZHOU) CO. LTD. · Double Medical Technology Inc. · Guangzhou Double One Latex Products Co., Ltd. · DOUBLE MEDICAL TECHNOLOGY INC · GUANGZHOU DOUBLE ONE LATEX PRODUCTS CO. LTD

Company information

Country
China
City
Guangzhou Guangdong

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

12016
22018
22022 · K221221
52023 · K233078
12024 · K242348
12025 · K252729

FDA listed device types

showing 8 of 17
Template 1Eraser, Dental Stain 1Strip, Polishing Agent 1Passer, Wire, Orthopedic 1Orthopedic Manual Surgical Instrument 1Posterior Cervical Screw System 1Rod, Fixation, Intramedullary And Accessories 1Thoracolumbosacral Pedicle Screw System 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252729Universal Spinal System2025-11-18
USK242348Locking Screw,CoCrMo2024-12-04
USK233078Posterior Cervical Spine System2023-11-22
BR82958150007Instrumentais Cirúrgicos em Aluminio para Implantes de Coluna - DMClass I
BR82958150008Instrumentais Cirúrgicos em Inox para Implantes de Coluna - DMClass I
BR82958150009Fixador Externo Dinâmico - DMClass I

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