Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010141954

FEI Number

3010141954

Entity Name

Sumitomo Bakelite (Dongguan) Co., Ltd.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

No. 2 Qiaolin Road Lingtou Industrial District, Qiaotou Town, Dongguan Guangdong 523530, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SB-KAWASUMI LABORATORIES, INC. (Owner Number: 8031539)

Owner / Operator Contact Address

3-25-4 Tonomachi, Kawasaki-ku, Kawasaki-shi, JP-14 210-8602, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Flexible Overtube SB Soft Hood Tentacles Tentacles NEO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-12-16
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-12-16
MWS	Stabilizer, Heart	Cardiovascular	Class 1	870.4500	2021-12-16

Official Correspondent

Kenichi Inamura

US Agent Details

Takahito Ishikawa Business: Sumitomo Plastics America, Inc. Email: t_ishikawa@sumibe.co.jp Phone: (408) 3355883

Related Public Records

Same Entity

SB-KAWASUMI LABORATORIES, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002806337	Akita Sumitomo Bakelite Co., Ltd.	Akita, JP
1055927	KAWASUMI LABORATORIES AMERICA, INC.	Tampa, FL, US
9615908	KAWASUMI LABORATORIES (THAILAND) CO., LTD.	CHOK CHAI Nakhon Ratchasima, TH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15
K232314	FUJIFILM Healthcare Americas Corporation	Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)	2023-09-01

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3011050570	Gyrus ACMI, Inc.	Brooklyn Park, MN, US
3035480112	SEPLOU (ZHUHAI) CO.,LTD.	Zhuhai Guangdong, CN
3012345110	Novadaq Technologies ULC	Burnaby British Columbia, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010141954. Last updated year: 2026. Please use registration number 3010141954 when referencing this establishment in official correspondence.