FDA Registration
Active
🇲🇽 Mexico
Giraffe Warmer
Reg #: 3008729547
·
FEI: 3008729547
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.
- Registration Number
- 3008729547
- FEI Number
- 3008729547
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- CALLE VALLE DEL CEDRO 1551
- City
- JUAREZ Chihuahua
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K090697
Owner / Operator
- Firm Name
- GE HealthCare Technologies Inc.
- Operator Number
- 9912004
- Address
- 3000 N. Grandview Blvd
- City
- Waukesha
- State
- WI
- Postal Code
- 53188
- Country
- US
US Agent
- Business Name
- GE HealthCare Technologies, Inc
- Contact Name
- Tracey Holevas
- Address
- 3000 N. Grandview BLVD
- City
- Waukesha
- State
- WI
- ZIP
- 53188
- Country
- US
- [email protected]
- Phone
- 262 3092157
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Warmer, Infant Radiant | FMT | Class 2 | General Hospital | No | 2010-07-28 |
Proprietary Names
Giraffe Warmer
Panda iRes Warmer
Panda Warmer
Establishment Types
Manufacture Medical Device