FDA Registration
Active
🇯🇵 Japan
KINJO RUBBER CO., LTD.
Reg #: 3015746529
·
FEI: 3015746529
·
Expires 2026
Products
3
Proprietary Names
56
Establishment Types
1
Classifications
3
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Registration Details
- Registration Name
- KINJO RUBBER CO., LTD.
- Registration Number
- 3015746529
- FEI Number
- 3015746529
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4-25, 1-Chome, Atobe-Kitanocho
- City
- Yao-City Osaka
- Country
- JP
Owner / Operator
- Firm Name
- Kinjo Rubber Co., Ltd.
- Operator Number
- 10094387
- Address
- 4-25, 1-Chome, Atobe-Kitanocho
- City
- Yao-City
- State
- Osaka
- Postal Code
- 581-0068
- Country
- JP
US Agent
- Business Name
- FUJIFILM Healthcare Americas Corporation
- Contact Name
- Randy Vader
- Address
- 81 Hartwell Ave Ste 100
- City
- Lexington
- State
- MA
- ZIP
- 02421
- Country
- US
- [email protected]
- Phone
- 360 3566821
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2025-12-12 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2025-12-12 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2025-11-26 |
Proprietary Names
Distal Cap Model DH-17EN2
Distal Cap Model DH-32EN
DH-083ST
DH-114STR
DH-104STR
DH-084STR
DH-124STR
DH-094STR
DH-134STR
FUJIFILM Hood Model DH-29CR
FUJIFILM Hood Model DH-30CR
FUJIFILM Hood Model DH-28GR
DH-126STL
DH-096ST
DH-106STL
DH-116STL
Distal Cap Models DH-33GR, DH-34CR, DH-40GR, DH-35GZ, DH-37CZ, DH-38CZ, DH-39CZ
LMP-002 LAMP ASSEMBLY FOR EPX-4400/4400HD
WA-7000 US Waterproof Cap
FV-003 Forceps Valve
CA-501JT/A Cleaning Adapter/G-5 Dual Channel
CA-601 Cleaning Adapter Kit for EG-530UR2/UT2
FV-001 Forceps Valve
CA-617 Cleaning Adapter
CA-614 Cleaning Adapter
CA-608 Cleaning Adapter
FV-002 Forceps Valve
AW-601 Air/Water Button for Ultrasonic Endoscope
FOV-LL2 Forceps Valve for EG-530UT2
LMP-001 LAMP ASSEMBLY FOR EPX-2200
LT-7F LEAKAGE TESTER
BA-1 Balloon Attachment Tool for EG-530UT2
AW-603 Air/Water Valve
BA-03 Balloon Attachment Tool
SB-604 Suction Valve
CA-610 Cleaning Adapter
CA-611 Air/Water Channel Cleaning Adapter
SB-601 Suction Button for Ultrasonic Endoscope
ST-10 Setting Tool
SB-605 Suction Valve
AW-602 Air/Water Valve
BA-BU1 Balloon Attachment Tool for EB-530US
CA-503/A Cleaning Adapter Kit for G-5 Endoscopes
FOV-DV7 Disposable Forceps Valve Cover for G-5 Endoscopes
CC7-301 Cable
CA-510/A Cleaning Adapter Kit /530 Series Endoscopes
AW-500 A-W BUTTON FOR G-5 SCOPES
CA-500D/A Cleaning Adapter
CA-503B/C Forceps Inlet Cleaning Adapter for G-5 Endoscopes
ST-01B Black Band Applicator for DBE
KE-007D
CA-609 Air/Water Channel Cleaning Adapter
CA-501FJ/A Cleaning Adapter /G-5 Dual Channel
ST-05B Single Use Balloon Applicator for DBE
SB-500 Suction Button for G-5 Scopes
CA-606 Balloon Channel Cleaning Adapter for EN-580T
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)