HomeChinaSumitomo Bakelite (Dongguan) Co., Ltd.

Sumitomo Bakelite (Dongguan) Co., Ltd.

China · Dongguan Guangdong
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, South Korea — 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
6listed device types
Class I 1Class II 5Class III 0
plus 7 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
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
1GMP quality-system certificates
Import 1
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 States7 registration records, 4 510(k), 0 PMA
Manufacturer names merged into this page: Sumitomo Bakelite (Dongguan) Co., Ltd. · Akita Sumitomo Bakelite Co., Ltd.
Same-named companies — This database also contains companies with near-identical names: Sumitomo Bakelite Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Dongguan 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 · K152771
12018 · K173004
22019 · K182520

FDA listed device types

Catheter, Continuous Flush 1Endoscopic Access Overtube, Gastroenterology-Urology 1Unit, Electrosurgical, Endoscopic (With Or Without Accessories) 1Gastroscope And Accessories, Flexible/Rigid 1Labware, Assisted Reproduction, Exempt 1Stabilizer, Heart 1

Registration details (sample)

MarketIdentifierNameClass / date
USK182520Flexible Overtube2019-05-15
USK190621SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long2019-04-23
USK173004SB Soft Hood - Straight type, SB Soft Hood - Undercut type2018-05-08

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