FDA Registration
Active
🇮🇳 India
OSI SYSTEMS PVT LTD(OPTOELECTRONICS DIVISION)
Reg #: 3021343210
·
FEI: 3021343210
·
Expires 2026
Products
10
Proprietary Names
17
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- OSI SYSTEMS PVT LTD(OPTOELECTRONICS DIVISION)
- Registration Number
- 3021343210
- FEI Number
- 3021343210
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1st and 2nd floor, GMR Aero Tower-2, Sy, No. 99/1, Mamidipally Village, Saroornagar Mandal, Ranga Reddy Distt (Near RGIA)
- City
- HYDERABAD Telangana
- Country
- IN
Owner / Operator
- Firm Name
- OSI Systems Pvt. Ltd(Optoelectronics division)
- Operator Number
- 9096780
- Address
- 1st and 2nd floor, GMR Aero Tower-2,, Sy, No. 99/1 (Near RGIA) Mamidipally Village, Saroornagar Mandal, Ranga Reddy Distt
- City
- Hyderabad
- State
- Telangana
- Postal Code
- 500108
- Country
- IN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2018-08-23 |
| Oximeter, Ear | DPZ | Class 2 | Cardiovascular | No | 2012-03-15 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2012-03-15 |
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2015-07-13 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2012-03-15 |
| Cardiograph, Apex (Vibrocardiograph) | DQH | Class 2 | Cardiovascular | No | 2012-03-15 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2015-07-13 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2015-07-13 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2015-07-13 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2015-07-13 |
Proprietary Names
7000X
6000CX
ADULT SPOT -CHECK SENSOR(WW1000,WW1020,WW1030)
PROBE FINGER PEDIATRIC RE-USABLE
FINGER PROBE - OXIMETRY
OXIMETRY PROBE UNIVERSAL Y
OXIMETRY EAR PROBE
DISPOSABLE PROBE
8203CA
8204CA
(CONFIDENTIAL) Dolphin Digital Sensors
OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM
SENSOR OXIM FNGR PRB COMFORT CLIP
PROBE OXIMETRY DISPOSABLE PEDIATRIC 10/BX
DISP OXIMETRY PROBE ADULT BX10 10/BX
DISP OXIMETRY PRO.NEONATE BX10 10/BX
DISP OXIMETRY PROBE INFNT BX10 10/BX
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)