FDA Registration
Active
🇯🇵 Japan
STERI-TECH CO.,LTD.
Reg #: 3015136743
·
FEI: 3015136743
·
Expires 2026
Products
11
Proprietary Names
75
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- STERI-TECH CO.,LTD.
- Registration Number
- 3015136743
- FEI Number
- 3015136743
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5-13-1 HANASAKI
- City
- KAZO-SHI Saitama
- Country
- JP
Owner / Operator
- Firm Name
- Steri-Tech Co.,Ltd.
- Operator Number
- 10059220
- Address
- 5-13-1 HANASAKI
- City
- KAZO-SHI
- State
- Saitama
- Postal Code
- 347-0032
- 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 |
|---|---|---|---|---|---|
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2022-01-12 |
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2022-01-12 |
| Forceps, Biopsy, Electric | KGE | Class 2 | Gastroenterology, Urology | No | 2019-12-06 |
| Enteroscope And Accessories | FDA | Class 2 | Gastroenterology, Urology | No | 2025-03-28 |
| Needle, Assisted Reproduction | MQE | Class 2 | Obstetrics/Gynecology | No | 2018-12-12 |
| Catheter, Assisted Reproduction | MQF | Class 2 | Obstetrics/Gynecology | No | 2018-12-12 |
| Device, Pressure Applying | KNM | Class 1 | Physical Medicine | No | 2020-12-17 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2018-12-17 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2023-12-28 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2022-01-12 |
| Needle, Acupuncture, Single Use | MQX | Class 2 | General Hospital | No | 2020-12-17 |
Proprietary Names
Distal Cap Model DH-17EN2
Distal Cap Model DH-32EN
"Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N15-"
"Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B30-"
"Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N30-"
"Fujifilm Diathermic Slitter (ClutchCutter) models DP2618DT -50-"
"Fujifilm Diathermic Slitter (ClutchCutter) models DP2618DT -35-"
"Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N20-"
"Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N25-"
Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -N10-
"Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B20-"
"Fujifilm Diathermic Slitter (FlushKnife) models DK2623J -N20-"
"Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B25-"
"Fujifilm Diathermic Slitter (FlushKnife) models DK2623J -N15-"
"Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B15-"
"Fujifilm Diathermic Slitter (FlushKnife) models DK2623J -B20-"
"Fujifilm Diathermic Slitter (FlushKnife) models DK2623J -B15-"
Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B25-
Fujifilm Diathermic Slitter (FlushKnife) models DK2618J -B20-
FUJIFILM Over-tube TS-1214C
FUJIFILM Hood Models DH-30CR
FUJIFILM Hood Models DH-28GR
FUJIFILM Hood Models DH-29CR
DH-083ST
Catheter 3Fr or 4Fr and Guide with Obturator
Catheter 3Fr or 4Fr
Stylet for Guide
Catheter 3Fr or 4Fr and Guide
SEIRIN PY Zero
SEIRIN Shonishin
SB-602 Suction Button for 530 Series Bronchoscopes (Sterile)
FUJIFILM Over-tube TR-1504A
FUJIFILM Over-tube TR-1507A
TR-1108A
Catheter 4.7Fr Supported (EC-PRO Supported)
Echogenic Trial Catheter 4.7Fr Supported (Trial EC-PRO Master Supported)
); Echogenic Catheter 4.7Fr(EC-PRO Master)
Stylet for Guide (EC-PRO Stylet)
KITAZATO ET Catheters; Catheters 4.7Fr(EC-PRO)
Echogenic Catheter 4.7Fr Supported (EC-PRO Master Supported)
Trial Catheter 4.7Fr (Trial EC-PRO)
Trial Catheter 4.7Fr Supported (Trial EC-PRO Supported)
Echogenic Trial Catheter 4.7Fr(Trial EC-PRO Master)
Single Use Suction Valve SB-606
Single Use Forceps Valve FV-003
Sterile Overtube models TS-13140
Sterile Overtube models TS-13101
Sterile Overtube models TS-12140
Kitazato OPU Reduced Needle (model number Type3)
Kitazato OPU Two-Stage Reduced Needle (model number Type4)
Kitazato OPU Needle with Connection Tube (model number Type2)
B20BU Balloon for EB-530US
Balloon BS-3
Distal Cap Models DH-34CR
Distal Cap Models DH-38CZ
Distal Cap Models DH-33GR
Distal Cap Models DH-37CZ
Distal Cap Models DH-35GZ
Distal Cap Models DH-40GR
Distal Cap Models DH-39CZ
Pyonex
Seirin Pyonex Needles
G-Type
J-15
B-Type
M-Type
D-Type
Spinex Intradermal
J ProPak10
J-Type
KB-Type
L-Type
ELIPEAS
DK2620JI FUJIFILM Diathermic Slitter (FlushKnife)
DK2623JI FUJIFILM Diathermic Slitter (FlushKnife)
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)