FDA Registration
Active
🇲🇽 Mexico
SB-80-200R
Reg #: 9616047
·
FEI: 3003377038
·
Expires 2025
Products
1
Proprietary Names
63
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V.
- Registration Number
- 9616047
- FEI Number
- 3003377038
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- CALLE ESPANA No. 300, PARQUE INDUSTRIAL HUINALA
- City
- APODACA Nuevo Leon
- Country
- MX
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 |
|---|---|---|---|---|---|
| Assembly, Tube Housing, X-Ray, Diagnostic | ITY | Class 1 | Radiology | No | 1999-10-06 |
Proprietary Names
SB-80-200R
MX100 CT Max
MX 75 TH.11
Artemis
STATORIX 550/RN620
MX165 NP
Performix Plus
5855555
Maxiray MX100 FL
MAXIRAY 70 TH-D
Performix HD Plus
MX200CT/Performix Ultra
MX100 CT Plus
Performix Pulsar
MAXIRAY 70 TH-F
LU8548STR
STATORIX 260/RSN742
MX100 RAD
LU45649STR
Statorix 240SV / MN640
MX100 FL
MAXIRAY 100 TH-M1
Vamana RAD
LU45649ST
LU40782
STATORIX 240/MSN740
Maxiray CT MAX
LU45645
MAXIRAY 70TH-M
APOLLON
STATORIX 240/MSN742
Solarix 350 Brightspeed
Quantix 160
MAXIRAY 120-09GW
MX135CT TH1.1
LU8548ST
LU8743STR
LU45645STR
LU43318ST
Performix HDw
MAXIRAY CT PLUS
Performix HD
43318
Performix 40 Plus
Brivo OEC 2.2A X-ray Generator
LU8743ST
Performix VCT Plus
LU45645ST
Performix 160A
Vamana Surgery
STATORIX 240SV / MN742
Performix Pro VCT 100
STATORIX 260/MSN740
STATORIX 260/MSN742
STATORIX 240SV / MN740
40782
Maxiray CT Ultra
Maxiray CT VCT
STATORIX 550/RSN722
Performix 40
45645
STATORIX 240/MN640
LU45649
Establishment Types
Manufacture Medical Device