Electrocardiogarph - India CDSCO Medical Device Registration

Electrocardiogarph is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000203_705c189fa94495799bcc7cf2b070e294_9c5b801103e874f55472e21b31fabfc6. This device is marketed under the brand name Spirovit. The license holder is Schiller Healthcare India Pvt Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Electrocardiogarph

UID: IMP/MD/2022/000203_705c189fa94495799bcc7cf2b070e294_9c5b801103e874f55472e21b31fabfc6

Brand Name

Spirovit

License Holder

Schiller Healthcare India Pvt Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

The CARDIOVIT AT-102 G2 is a 12-lead ECG and spirometry (Spirovit) device intended to be used by trained medical professionals in healthcare facilities for cardiological diagnosis in adult and paediatric patients. ECG and spirometry analysis is complemented with algorithms that provide measurement results, data, graphic presentation and interpretation for review by the user. Patient data is exchanged between the CARDIOVIT AT-102 G2 and a data management system by means of USB stick, LAN or WLAN