FDA Registration
Active
🇮🇳 India
Star 65
Reg #: 3009001657
·
FEI: 3009001657
·
Expires 2025
Products
19
Proprietary Names
1
Establishment Types
2
Classifications
19
Registration Details
- Registration Name
- SKANRAY TECHNOLOGIES LIMITED
- Registration Number
- 3009001657
- FEI Number
- 3009001657
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Plot# 15-17, Hebbal Industrial Area, Hebbal
- City
- Mysore Karnataka
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K172147
Owner / Operator
- Firm Name
- Skanray Technologies Limited
- Operator Number
- 10036010
- Address
- Plot #15-17, Hebbal Industrial Area, Hebbal
- City
- Mysore
- State
- Karnataka
- Postal Code
- 570016
- Country
- IN
- Correspondent
- Vasundhara R
US Agent
- Business Name
- Elexes Medical Consulting
- Contact Name
- Dana S
- Address
- 218 Eclipse Drive, Bordentown
- City
- Bordentown
- State
- NJ
- ZIP
- 08505
- Country
- US
- [email protected]
- Phone
- 732 6475105 ext. 1
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2022-12-06 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2022-12-06 |
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2022-12-06 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2022-12-06 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2022-12-06 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2022-12-06 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2022-12-06 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2022-12-06 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2022-12-06 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2022-12-06 |
| Recorder, Paper Chart | DSF | Class 1 | Cardiovascular | No | 2022-12-06 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2022-12-06 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2022-12-06 |
| Probe, Thermodilution | KRB | Class 2 | Cardiovascular | No | 2022-12-06 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-12-06 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2022-12-06 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2022-12-06 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2022-12-06 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2022-12-06 |
Proprietary Names
Star 65
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device