uzinmedical.co.krSpectra Wearable
Uzinmedicare Co., Ltd.
Uzinmedicare
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011139154 | 3011139154 | Uzinmedicare Co., Ltd. | 1 | N | 2026-01-01 | 54, 56, 60 Dongtansandan 5-gil Hwaseong-si Gyeonggi KR 18487 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 18809108011364 | Spectra - This is powered breast pump to be used by lactating women to express and collect milk from their breasts. The final product is packed in a box with neccessary connecting parts including breast shield, head, membrane, tubing, backflow protector,bottle, and instruction for use, so the user can use the device right after receving them. | +821053081195 | shahn@uzinmedical.co.kr |
| 28809108011316 | Spectra - This is powered breast pump to be used by lactating women to express and collect milk from their breasts. The final product is packed in a box with neccessary connecting parts including breast shield, head, membrane, tubing, backflow protector,bottle, and instruction for use, so the user can use the device right after receving them. | +821053081195 | shahn@uzinmedical.co.kr |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 199956 | 1340514785 | K251932 | Spectra Platinum | HGX | 2025-11-25 |
| 199956 | 1025835057 | K251423 | Spectra S1 Pro; Spectra S2 Pro | HGX | 2026-02-06 |
| 199956 | 1547616233 | K250208 | SPECTRA Wearable 2 | HGX | 2026-04-06 |
| 199956 | 1519073015 | K220926 | Spectra Wearable | HGX | 2022-12-12 |
| 199956 | 1395238612 | K210124 | Synergy Gold (SG) Portable (Models MM011450 and MM011460) | HGX | 2021-10-19 |
| 199956 | 1120554550 | K191208 | Spectra Cashmere | HGX | 2019-10-11 |
| 199956 | 1627908331 | K191109 | Spectra Q | HGX | 2020-01-22 |
| 199956 | 1850935240 | K181784 | Spectra S3 Plus | HGX | 2018-11-30 |
| 199956 | 1270521958 | K162415 | Spectra 9Plus | HGX | 2017-03-15 |
| 199956 | 1491387854 | K150476 | Spectra S1Plus and Spectra S2 Plus | HGX | 2016-04-15 |
| 199956 | 1530223978 | K093145 | SPECTRA SERIES BREAST PUMP | HGX | 2010-08-13 |
| 199956 | 1572739450 | ||||
| 199956 | 1365593599 | ||||
| 199956 | 1776360324 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HGX | 15 | 2026-04-06 |
PMN#
Synergy Gold (SG) Portable (Models MM011450 And MM011460)
Uzinmedicare Co.
Spectra Q
Uzinmedicare Co.
Spectra Cashmere
Uzinmedicare Co.
Spectra S3 Plus
Uzinmedicare Co.
Spectra 9Plus
Uzinmedicare Company
Spectra S1Plus And Spectra S2 Plus
UZINMEDICARE CO.
SPECTRA SERIES BREAST PUMP
UZINMEDICARE CO.
GUDID#
Spectra - This is powered breast pump to be used by lactating women to express and collect milk from their breasts. The final product is packed in a box with neccessary connecting parts including breast shield, head, membrane, tubing, backflow protector,bottle, and instruction for use, so the user can use the device right after receving them.
2020-04-30
Spectra - 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.
2019-10-19
Spectra - This is a funnel shaped accessory, which come in contact with breat to express milk.
2019-04-05
Spectra - This is a funnel shaped accessory, which come in contact with breat to express milk.
2019-04-05
Spectra - This is a funnel shaped accessory, which come in contact with breat to express milk.
2019-04-05
Spectra - This is powered breast pump to be used by lactating women to express and collect milk from their breasts. The final product is packed in a box with neccessary connecting parts including breast shield, head, membrane, tubing, backflow protector,bottle, and instruction for use, so the user can use the device right after receving them.
2019-03-22
Spectra - 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. It typically includes various items such as funnel-like breast shields, tubing, connectors, and infant feeding bottle. This is a reusable device.
2019-03-22