FDA Registration
Active
🇯🇵 Japan
Lourdes; OHCO
Reg #: 3014133483
·
FEI: 3014133483
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
10
Classifications
1
Registration Details
- Registration Name
- ATEX CO., LTD.
- Registration Number
- 3014133483
- FEI Number
- 3014133483
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3-3-24 Nagayoshi-kawanabe, Hirano-ku
- City
- Osaka
- Country
- JP
Owner / Operator
- Firm Name
- ATEX Co., Ltd.
- Operator Number
- 10060111
- Address
- 3-3-24 Nagayoshi-kawanabe, Hirano-ku
- City
- Osaka
- State
- JP-27
- Postal Code
- 547-0014
- Country
- JP
- Correspondent
- MAYUMI AKAMATSU
US Agent
- Business Name
- FIUS Distributors, LLC
- Contact Name
- Cliff Levin
- Address
- 2125 32nd Street, Ste A
- City
- Boulder
- State
- CO
- ZIP
- 80301
- Country
- US
- [email protected]
- Phone
- 303 5725000
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2019-03-31 |
Proprietary Names
Lourdes; OHCO
Establishment Types
Reprocess Single-Use Device
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Remanufacture Medical Device
Foreign Private Label Distributor
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device