X-ray Machine - India CDSCO Medical Device Registration

X-ray Machine is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000772_39bb1d58cf9d6d01add754957497feed_4c813730726a59b3ce6d2c83c2e0d450. This device is marketed under the brand name Dental Hand-held X-ray Device. The license holder is Orikam Healthcare India Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is Sub Zonal Baddi.

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CDSCO Registered

Class Class C

X-ray Machine

UID: MFG/MD/2023/000772_39bb1d58cf9d6d01add754957497feed_4c813730726a59b3ce6d2c83c2e0d450

Brand Name

Dental Hand-held X-ray Device

License Holder

Orikam Healthcare India Pvt. Ltd.

Device Class

Class C

Approving Authority

Sub Zonal Baddi

Product Information

The Orikam Eighteeth HyperLight is indicated for use only by a trained and qualified dentist or dental technician (Dental Hand-held X-ray Device) for both adult and paediatric subjects as an extra-oral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. This device must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel.

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