FDA Registration
Active
🇲🇽 Mexico
Coverall Shields
Reg #: 3006582165
·
FEI: 3006582165
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
5
Classifications
1
Registration Details
- Registration Name
- MANUFACTURAS KE
- Registration Number
- 3006582165
- FEI Number
- 3006582165
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Alejandro Perez Rocha, 82
- City
- Nogales Sonora
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K882028
Owner / Operator
- Firm Name
- Manufacturas KE
- Operator Number
- 10032451
- Address
- Alejandro Perez Rocha, 82
- City
- Nogales
- State
- Sonora
- Postal Code
- 84094
- Country
- MX
- Correspondent
- Francisco J Rivera
US Agent
- Business Name
- Alpha ProTech Inc
- Contact Name
- Beatriz O'Daly
- Address
- 1600 W La Quinta Rd Ste 1
- City
- Nogales
- State
- AZ
- ZIP
- 85621
- Country
- US
- [email protected]
- Phone
- 520 8600060
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2010-05-13 |
Proprietary Names
Coverall Shields
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Remanufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Manufacture Medical Device