uzinmedicare.comSpectra Wearable
Uzinmedicare Co., Ltd.
Uzinmedicare Co., Ltd.
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 | |
|---|---|---|---|
| 00889108018496 | Spectra - Spectra accessory set for breast pump including 24mm breast shield set. | +821099269027 | ghwns57@uzinmedicare.com |
| 08809108018496 | Spectra - Spectra accessory set for breast pump including 24mm breast shield set. | +821099269027 | ghwns57@uzinmedicare.com |
| 08809108020017 | Spectra - Spectra accessory set for breast pump including 20mm breast shield set. (Sealing cap for milk bottle) | +821099269027 | ghwns57@uzinmedicare.com |
| 08809108020024 | Spectra - Spectra accessory set for breast pump including 24mm breast shield set.(Sealing cap for milk bottle) | +821099269027 | ghwns57@uzinmedicare.com |
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 - Spectra accessory set for breast pump including 24mm breast shield set.(Sealing cap for milk bottle)
2026-04-30
Spectra - Spectra accessory set for breast pump including 20mm breast shield set. (Sealing cap for milk bottle)
2026-04-30
Spectra - Spectra accessory set for breast pump including 24mm breast shield set.
2025-10-15
Spectra - Spectra accessory set for breast pump including 24mm breast shield set.
2026-01-23
Spectra - Breast milk storage bottle package
2026-02-27
Spectra - Breast milk storage bottle package
2026-02-27
Spectra - Spectra Allset PP Bottle Set (2-pack, Sealing cap for milk bottle)
2026-02-03
Spectra - Spectra accessory set for breast pump including 32mm breast shield set. (Sealing cap for milk bottle)
2026-02-03
Spectra - Spectra accessory set for breast pump including 28mm breast shield set. (Sealing cap for milk bottle)
2026-02-03
Spectra - Spectra accessory set for breast pump including 24mm breast shield set.(Sealing cap for milk bottle)
2026-02-03
Spectra - Spectra accessory set for breast pump including 20mm breast shield set. (Sealing cap for milk bottle)
2026-02-03
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(flange), Silicone valve, tubing, backflow protector, bottle, and instruction for use, sealing cap for milk bottle, so the user can use the device right after receving them.
2026-02-03
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, tubing, back-flow protector, silicone valve, bottle set, adapter, and instruction for use, sealing cap for milk bottle, so the user can use the device right after receving them.
2026-02-03
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, tubing, back-flow protector, silicone valve, bottle set, adapter, and instruction for use, sealing cap for milk bottle, so the user can use the device right after receving them.
2026-02-03
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, tubing, back-flow protector, silicone valve, bottle set, adapter and instruction for use, sealing cap for milk bottle, so the user can use the device right after receving them.
2026-02-03
Spectra - Spectra Allset PP Bottle Set (2-pack, Sealing cap for milk bottle)
2026-02-03
Spectra - Spectra accessory set for breast pump including 32mm breast shield set. (Sealing cap for milk bottle)
2026-02-03
Spectra - Spectra accessory set for breast pump including 28mm breast shield set. (Sealing cap for milk bottle)
2026-02-03
Spectra - Spectra accessory set for breast pump including 24mm breast shield set.(Sealing cap for milk bottle)
2026-02-03
Spectra - Spectra accessory set for breast pump including 20mm breast shield set. (Sealing cap for milk bottle)
2026-02-03
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(flange), Silicone valve, tubing, backflow protector, bottle, and instruction for use, sealing cap for milk bottle, so the user can use the device right after receving them.
2026-02-03
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, tubing, back-flow protector, silicone valve, bottle set, adapter, and instruction for use, sealing cap for milk bottle, so the user can use the device right after receving them.
2026-02-03
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, tubing, back-flow protector, silicone valve, bottle set, adapter, and instruction for use, sealing cap for milk bottle, so the user can use the device right after receving them.
2026-02-03
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, tubing, back-flow protector, silicone valve, bottle set, adapter and instruction for use, sealing cap for milk bottle, so the user can use the device right after receving them.
2026-02-03
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, tubing, back-flow protector, bottle set, adapter, and instruction for use, sealing cap for milk bottle, so the user can use the device right after receving them.
2026-01-26
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, tubing, back-flow protector, bottle set, adapter, and instruction for use, sealing cap for milk bottle, so the user can use the device right after receving them.
2026-01-26
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, tubing, back-flow protector, bottle set, adapter, and instruction for use, sealing cap for milk bottle, so the user can use the device right after receving them.
2026-01-26
Spectra - Spectra accessory set for breast pump including 24mm breast shield set.
2026-01-23
Spectra - Cooler Kit
2026-01-22
Spectra - Cooler Kit
2026-01-22
Spectra - Cooler Kit
2025-12-02
Spectra - Breast milk storage bottle package
2025-12-02
Spectra - Cooler Kit
2025-12-02
Spectra - Breast milk storage bottle package
2025-12-02
Spectra - The Spectra Wearable is powered breast pumps intended for use of lactating women to stimulate, express and collect milk from user’s breast.The final product is packed in a box with neccessary parts including breast shied, silicone valve, silicone membrane, bottle, bottle connector, connector pin, airtight cap, pp bottle, nipple, screw cap, cover, power adapter and instruction for use.
2025-10-15
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(flange), Silicone valve, tubing, backflow protector, bottle, cara cup and instruction for use, so the user can use the device right after receving them.
2025-10-15
Spectra - This is a 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 necessary connecting parts including Cara Cups, and instruction for use. So the user can use the device right after receiving them.
2025-10-15
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.
2025-10-15
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(flange), Silicone valve, tubing, backflow protector, bottle, and instruction for use, so the user can use the device right after receving them.
2025-10-15
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, tubing, back-flow protector, silicone valve, bottle set, adapter, and instruction for use, so the user can use the device right after receving them.
2025-10-15