FDA Registration
Active
🇨🇳 China
Sumitomo Bakelite (Dongguan) Co., Ltd.
Reg #: 3010141954
·
FEI: 3010141954
·
Expires 2026
Products
3
Proprietary Names
4
Establishment Types
2
Classifications
3
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Registration Details
- Registration Name
- Sumitomo Bakelite (Dongguan) Co., Ltd.
- Registration Number
- 3010141954
- FEI Number
- 3010141954
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 2 Qiaolin Road Lingtou Industrial District, Qiaotou Town
- City
- Dongguan Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- SB-KAWASUMI LABORATORIES, INC.
- Operator Number
- 8031539
- Address
- 3-25-4 Tonomachi, Kawasaki-ku
- City
- Kawasaki-shi
- State
- Kanagawa
- Postal Code
- 210-8602
- Country
- JP
- Correspondent
- Kenichi - Inamura
US Agent
- Business Name
- Sumitomo Plastics America, Inc.
- Contact Name
- Takahito Ishikawa
- Address
- 4675 Stevens Creek Blvd Ste 101
- City
- Santa Clara
- State
- CA
- ZIP
- 95051
- Country
- US
- [email protected]
- Phone
- 408 3355883
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2021-12-16 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2021-12-16 |
| Stabilizer, Heart | MWS | Class 1 | Cardiovascular | No | 2021-12-16 |
Proprietary Names
Flexible Overtube
SB Soft Hood
Tentacles
Tentacles NEO
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)