UNIMOM CO.

Address:110-19, GAJANGSANEOPSEOBUK-RO,Osan-si Gyeonggi,KR

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Filters

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, Powered (HGX) (9) Pump, Breast, Non-Powered (HGY) (1)

Premarket Exempt

No Yes

Clear

Unimom - 08809224871135 Catalog Number :

Device Description : Manual Breast Pump

Device Class : 1

Duns Number: 689057658

Premarket Exempt : Yes

Product Code : HGY

Prescription Use : No

Device Count : 1

Unimom - 08809224871289 Catalog Number :

Device Description : This is a funnel shaped accessory, which come in contact with breast to express milk.

Device Class : 2

Duns Number: 689057658

Premarket Exempt : Yes

Product Code : HGX

Prescription Use : No

Device Count : 1

Unimom - 08809224871364 Catalog Number :

Device Description : This is a funnel shaped accessory, which come in contact with breast to express milk.

Device Class : 2

Duns Number: 689057658

Premarket Exempt : Yes

Product Code : HGX

Prescription Use : No

Device Count : 1

Unimom - 08809224872019 Catalog Number :

Device Description : The MINUET LCD is multiple-user, powered breast pumps intended to help a mother, The MINUET LCD is multiple-user, powered breast pumps intended to help a mother, especially those who have an excess of milk or have difficulty breast-feeding, extract residual milk from her breast.

Device Class : 2

Duns Number: 689057658

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Unimom - 08809224872026 Catalog Number :

Device Description : Unimom accessory(24mm shield set)

Device Class : 2

Duns Number: 689057658

Premarket Exempt : Yes

Product Code : HGX

Prescription Use : No

Device Count : 1

Unimom - 08809224872088 Catalog Number :

Device Description : Unimom accessory(27mm shield set)

Device Class : 2

Duns Number: 689057658

Premarket Exempt : Yes

Product Code : HGX

Prescription Use : No

Device Count : 1

Unimom - 08809224872217 Catalog Number :

Device Description : This is a funnel shaped accessory, which come in contact with breast to express milk.

Device Class : 2

Duns Number: 689057658

Premarket Exempt : Yes

Product Code : HGX

Prescription Use : No

Device Count : 1

Unimom - 08809224872224 Catalog Number :

Device Description : Unimom accessory(30mm shield set)

Device Class : 2

Duns Number: 689057658

Premarket Exempt : Yes

Product Code : HGX

Prescription Use : No

Device Count : 1

Unimom - 08809224872262 Catalog Number :

Device Description : The Opera is multiple-user, powered breast pumps intended to help a mother, espe The Opera is multiple-user, powered breast pumps intended to help a mother, especially those who have an excess of milk or have difficulty breast-feeding, extract residual milk from her breast

Device Class : 2

Duns Number: 689057658

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Unimom - 08809224872279 Catalog Number :

Device Description : The Opera eco is multiple-user, powered breast pumps intended to help a mother, The Opera eco is multiple-user, powered breast pumps intended to help a mother, especially those who have an excess of milk or have difficulty breast-feeding, extract residual milk from her breast

Device Class : 2

Duns Number: 689057658

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

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