UZINMEDICARE CO.,LTD

Address:56, Dongtansandan 5-gil,Hwaseong-si Gyeonggi,KR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Pump, Breast, Non-Powered (HGY) (1) Pump, Breast, Powered (HGX) (1)

Premarket Exempt

Yes No

Clear

Spectra - 08809108015051 Catalog Number :

Device Description : A collection of non-sterile items intended to be used in conjunction with a manu A collection of non-sterile items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. This is a reusable device.

Device Class :

Duns Number: 688451947

Premarket Exempt : Yes

Product Code : HGX

Prescription Use : No

Device Count : 96

Spectra - 08809108017550 Catalog Number :

Device Description : A hand-held device used to extract milk from the breast, typically for collectin A hand-held device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a low-grade suction through a funnel-like component that is applied to the breast and is typically operated by the donor; the milk collects in an attached vessel (e.g., a sterilized bottle). This is a reusable device.

Device Class : 1

Duns Number: 688451947

Premarket Exempt : No

Product Code : HGY

Prescription Use : No

Device Count : 1

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