Spirometer - India CDSCO Medical Device Registration

Spirometer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000448_7cb407104cb2d917e2c129a8bf681b78_612538ff509cea2f805c2f055493ae2a. This device is marketed under the brand name Safey. The license holder is Safey Medical Devices Private Limited, and it is classified as Device Class Class B. The approving authority is Pune Division.

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CDSCO Registered

Class Class B

Spirometer

UID: MFG/MD/2022/000448_7cb407104cb2d917e2c129a8bf681b78_612538ff509cea2f805c2f055493ae2a

Brand Name

Safey

License Holder

Safey Medical Devices Private Limited

Device Class

Class B

Approving Authority

Pune Division

Product Information

Safey Pocket Spirometer is intended to be used by patients above 5 years of age to perform basic lung function tests under the instruction of a physician or practitioner licensed by law to measure the health of the lung. Safey Pocket Spirometer can also be used by Physician or practitioner licensed by law to measure the health of the lung of their patients. It is intended to be used under Home Healthcare environment and Professional Healthcare Environment. Safey Clinic Spirometer is intended to be used by patients above 5 years of age to perform basic lung function tests under the instruction of a physician or practitioner licensed by law to measure the health of the lung. Safey Clinic Spirometer can also be used by Physician or practitioner licensed by law to measure the health of the lung of their patients. It is intended to be used under Home Healthcare environment and Professional Healthcare Environment. Safey Peak Flow Meter is intended to measure Peak Expiratory Flow (Safey) and Forced Expiratory Volume in one second (Safey) in home and professional healthcare environment. The device is designed for children greater than five years of age, adolescent and adult subjects.