HomeChinaSHENZHEN DENCO MEDICAL CO., LTD.

SHENZHEN DENCO MEDICAL CO., LTD.

China · Shenzhen Guangdong
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia, Israel, Russia — 7 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
52listed device types
Class I 51Class II 1Class III 0
plus 52 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
15registered devices
Class I 13Class II 2
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
9registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
7valid device licences
Class I 7
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
7active ARTG entries
Class I 4IIa 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
RURussiaRoszdravnadzor
8active registrations
Class 1 2Class 2a 6
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 States52 registration records, 0 510(k), 0 PMA, 1 excluded
Brazil15 confirmed, 0 excluded
Saudi Arabia9 confirmed, 0 excluded
Manufacturer names merged into this page: SHENZHEN DENCO MEDICAL CO., LTD. · SHENZHEN DENCO MEDICAL CO., LTD · SHENZHEN DENCO MEDICAL CO,.LTD · Shenzhen Denco Medical Co., Ltd · SHENZHEN DENCO MEDICAL CO

Company information

Country
China
City
Shenzhen 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 listed device types

showing 8 of 52
Evacuator, Oral Cavity 1Band, Preformed, Orthodontic 1Syringe, Restorative And Impression Material 1Unit, Suction Operatory 1Pick, Massaging 1Accessories, Implant, Dental, Endosseous 1Instrument, Contouring, Matrix, Operative 1Drill, Dental, Intraoral 1

Registration details (sample)

MarketIdentifierNameClass / date
BR81593730032PONTA DE ULTRA-SOM IMPLAClass I
BR81960650001LIMAS ENDODÔNTICAS DENCOClass I
BR81960650002LIMA ENDODÔNTICA DENCO ACIONADA POR MOTORClass I
SAME0000000569SFDAA00002SUPER FILES
SAME0000014326SFDAA00008H-FILES

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