FDA Registration
Active
🇯🇵 Japan
TOCHIGICHIZUKA PLANT
Reg #: 3017140456
·
FEI: 3017140456
·
Expires 2026
Products
6
Proprietary Names
10
Establishment Types
1
Classifications
6
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Registration Details
- Registration Name
- TOCHIGICHIZUKA PLANT
- Registration Number
- 3017140456
- FEI Number
- 3017140456
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1705 CHIZUKA-MACHI
- City
- Chizuka, Tochigi
- Country
- JP
Owner / Operator
- Firm Name
- Fuji Latex Co., LTD.
- Operator Number
- 10029059
- Address
- 19-1, 3-chome, Kanda Nishiki-cho, Chiyoda-ku
- City
- Tokyo
- State
- JP-13
- Postal Code
- 101-0054
- Country
- JP
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2020-06-22 |
| Endoscopic Ultrasound System, Gastroenterology-Urology | ODG | Class 2 | Gastroenterology, Urology | No | 2020-06-22 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2020-06-22 |
| Enteroscope And Accessories | FDA | Class 2 | Gastroenterology, Urology | No | 2020-06-22 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2020-06-22 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2020-06-22 |
Proprietary Names
PENTAX Single Use Balloon OF-A67
PENTAX Single Use Balloon OE-A52
BS-2
PENTAX Single Use Balloon OE-A51
PENTAX Single Use Balloon OE-A56
B20BU
B20UT
B20UR
PENTAX Medical Single Use Balloon OE-A60
PENTAX Medical Single Use Balloon OE-A61
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)