FDA Registration
Active
🇯🇵 Japan
Stylet for Guide
Reg #: 3015136743
·
FEI: 3015136743
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STERI-TECH CO.,LTD.
- Registration Number
- 3015136743
- FEI Number
- 3015136743
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5-13-1 HANASAKI
- City
- KAZO-SHI Saitama
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K192540
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 |
|---|---|---|---|---|---|
| Catheter, Assisted Reproduction | MQF | Class 2 | Obstetrics/Gynecology | No | 2022-01-12 |
Proprietary Names
Stylet for Guide
Catheter 3Fr or 4Fr
Catheter 3Fr or 4Fr and Guide with Obturator
Catheter 3Fr or 4Fr and Guide
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)