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Electrocardiograph for Stress Test System - India CDSCO Medical Device Registration

Electrocardiograph for Stress Test System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000001_6201895a409858f0017db3e2d207c9e3_68f4a0838723a4a6aa9a5559edec6f59. This device is marketed under the brand name Spandan. The license holder is Schiller Healthcare India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is Puducherry.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class B
Electrocardiograph for Stress Test System
UID: MFG/MD/2023/000001_6201895a409858f0017db3e2d207c9e3_68f4a0838723a4a6aa9a5559edec6f59

Brand Name

Spandan

Device Class

Class B

Approving Authority

Puducherry

Product Information

SPANDAN is a 12-channel ECG device used for the recording, analysis and evaluation of ECG Recordings. Recordings made with SPANDAN can be used as a diagnostic aid for heart function and heart conditions. The diagnostic applications for which the SPANDAN is intended is in the diagnosis of cardiac abnormalities in the general population, detecting acute myocardial ischemia, and infarction in chest pain patients, etc. The SPANDAN is intended for use in hospitals, cardio logical units, out-patient clinical units, and general practice, for indoor use only. There is no danger for patients with pacemaker. Only operate the device in accordance with the specified technical data. The device is not designed for sterile use. Do not use this unit in areas where there is any danger of explosion or in the presence of flammable gases such as anaesthetic agents. This unit is CF classified and defibrillation protected, only when the original patient cable is used. However, as a safety precaution when possible, remove electrodes before defibrillation. Spandan is a 12-channel ECG device which is connected with Treadmill and its accessories and used for the recording, analysis and evaluation of ECG Recordings. Recordings made with the Spandan can be used as a diagnostic aid for heart function and heart conditions. It is designed for indoor use and can be used for all patients of both sexes, all races, and aged more than 5 years

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