Neonatal garments - India CDSCO Medical Device Registration

Neonatal garments is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000590_22ef0552555f83068d889b4703765b70_2bf723ffdc3ad4960d62b3cf9ed6c654. This device is marketed under the brand name PSI. The license holder is Plasti Surge Industries Pvt Ltd, and it is classified as Device Class Class A. The approving authority is Amravati Division.

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CDSCO Registered

Class Class A

Neonatal garments

UID: MFG/MD/2022/000590_22ef0552555f83068d889b4703765b70_2bf723ffdc3ad4960d62b3cf9ed6c654

Brand Name

PSI

License Holder

Plasti Surge Industries Pvt Ltd

Device Class

Class A

Approving Authority

Amravati Division

Product Information

A non-sterile, upper & lower body garment intended to allow a parent to safely carry/support their premature, dysmature, and/or sick infant, in a manner which enables skin-to-skin contact between parent and infant . It typically consists of a nappies, mittens, gloves, cap, wrap/sweater, with a variety of straps, and pockets to accommodate ventilation, monitoring, feeding, and warming devices. This is a reusable, garment

Class A

Isolation gown - Non sterile

Brand: PSI

Plasti Surge Industries Pvt Ltd

Class A

Brand: PSI

Class A