FDA Registration
Active
🇲🇽 Mexico
Flextronics Manufacturing Aguascalientes, S.A de C.V
Reg #: 3003600763
·
FEI: 3003600763
·
Expires 2026
Products
16
Proprietary Names
31
Establishment Types
1
Classifications
16
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Registration Details
- Registration Name
- Flextronics Manufacturing Aguascalientes, S.A de C.V
- Registration Number
- 3003600763
- FEI Number
- 3003600763
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Boulevard a Zacatecas, Km 9.5, Jesús María
- City
- Aguascalientes
- Country
- MX
Owner / Operator
- Firm Name
- Flextronics International USA, Inc.
- Operator Number
- 9006592
- Address
- 12455 Research Blvd
- City
- Austin
- State
- TX
- Postal Code
- 78759
- Country
- US
- Correspondent
- Chad Ashton
US Agent
- Business Name
- FLEXTRONICS INTERNATIONAL USA, INC.
- Contact Name
- Chad Ashton
- Address
- 12455 Research Blvd
- City
- Austin
- State
- TX
- ZIP
- 78759
- Country
- US
- [email protected]
- Phone
- 901 8712423
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2023-07-05 |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | Class 2 | Clinical Chemistry | No | 2023-07-05 |
| Bed, Pediatric Open Hospital | FMS | Class 2 | General Hospital | No | 2010-12-08 |
| Densitometer, Bone | KGI | Class 2 | Radiology | No | 2016-09-27 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2014-11-26 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2014-11-26 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2014-11-26 |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems | QLG | Class 2 | Clinical Chemistry | No | 2025-07-14 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2009-01-05 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2009-01-05 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2009-01-05 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2016-09-28 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2016-09-28 |
| Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated | PZE | Class 3 | Unknown | No | 2017-10-11 |
| Bed, Ac-Powered Adjustable Hospital | FNL | Class 2 | General Hospital | No | 2010-12-08 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2014-05-09 |
Proprietary Names
Bed - Pediatric, Open Hospital, Cub, HAVASU IV Pole, (Accessory)
Discovery Ci; Discovery Wi; Horizon A; Horizon C; Horizon Ci; Horizon W; Horizon Wi
PEGASUS PRT19550-220: FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
FreeStyle Libre 3 Reader Kits
FreeStyle Libre 2 Reader Kits
Instinct Sensor
FreeStyle Libre 2 Plus Sensor Kits
FreeStyle Libre 3 Plus Sensor Kits
LFR Glucose dehydrogenase, glucose, OTC, Freestyle
SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER
INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
Freestyle Libre 2 Flash Glucose Monitoring System
PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
PRECISION XTRA ADVANCED DIABETES MA
FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
PRT 26909-780, ASSY, METER, FS PRECISION NEO INDICATORS, SW 1.18, MG/DL, US, NEO-F, 26909
Freestyle Libre Flash Glucose Monitoring System:PRT29000-510 - ASSY, READER, SYSTEM D, MG/DL, 29000, EN-US , GOVT
Freestyle Libre Flash Glucose Monitoring System (System A, PRT22175-123, PRT22175-124, PRT26662-005 (S/A)
Freestyle Libre Flash Glucose Monitoring System:PRT22175-137 - ASSY, READER, SYSTEM A, MG/DL, 22175, EN-US/ES-US, GOVT, NFRS
Freestyle Libre Flash Glucose Monitoring System:PRT22175-135 - ASSY, READER, SYSTEM A, MG/DL, 22175, EN-US/ES-US, GOVT
GoBed II
In Touch (w/Wireless)
AC Powered adjustable hospital bed
AC Powered
Beds, AC Powered
Beds
HAVASU IV Pole (Accessory)
Gemini2 PRT22300-010
Precision Xceed Pro Blood Glucose a
PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS
RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)