FDA Registration
Active
🇯🇵 Japan
Cryotec (10 pieces) (Yellow)
Reg #: 3013019894
·
FEI: 3013019894
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- REPROLIFE INC.
- Registration Number
- 3013019894
- FEI Number
- 3013019894
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2-5-3-9F Shinjuku
- City
- Shinjuku-ku Tokyo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K162051
Owner / Operator
- Firm Name
- REPROLIFE Inc.
- Operator Number
- 10054077
- Address
- 2-5-3-9F Shinjuku
- City
- Shinjuku-ku
- State
- Tokyo
- Postal Code
- 160-0022
- Country
- JP
- Correspondent
- Shin Tanaka
US Agent
- Business Name
- Globizz Corp
- Contact Name
- Takahiro Haruyama
- Address
- 970 W. 190th St. Suite 200
- City
- Torrance
- State
- CA
- ZIP
- 90502
- Country
- US
- [email protected]
- Phone
- 310 5383860
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2017-02-08 |
Proprietary Names
Cryotec (10 pieces) (Yellow)
Cryotec (10 pieces) (White)
Cryotec (10 pieces) (Red)
Cryotec (10 pieces) (Blue)
Cryotec (10 pieces) (Green)
Cryotec (4 pieces) (Green)
Cryotec (4 pieces) (Red)
Cryotec (4 pieces) (White)
Cryotec (4 pieces) (Blue)
Cryotec (4 pieces) (Yellow)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device