Uzinmedicare Co., Ltd.
Hwaseong-si Gyeonggi, KR
Uzinmedicare Co., Ltd. appears in FDA device records in Hwaseong-si Gyeonggi, KR. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Uzinmedicare Co., Ltd. between 2010 and 2026. The busiest year on record is 2026, with 3. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2025 | 1 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260956 | Spectra Platinum Mini | HGX | Substantially Equivalent | |
| K250208 | SPECTRA Wearable 2 | HGX | Substantially Equivalent | |
| K251423 | Spectra S1 Pro; Spectra S2 Pro | HGX | Substantially Equivalent | |
| K251932 | Spectra Platinum | HGX | Substantially Equivalent | |
| K220926 | Spectra Wearable | HGX | Substantially Equivalent | |
| K210124 | Synergy Gold (SG) Portable (Models MM011450 and MM011460) | HGX | Substantially Equivalent | |
| K191109 | Spectra Q | HGX | Substantially Equivalent | |
| K191208 | Spectra Cashmere | HGX | Substantially Equivalent | |
| K181784 | Spectra S3 Plus | HGX | Substantially Equivalent | |
| K162415 | Spectra 9Plus | HGX | Substantially Equivalent | |
| K150476 | Spectra S1Plus and Spectra S2 Plus | HGX | Substantially Equivalent | |
| K093145 | SPECTRA SERIES BREAST PUMP | HGX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011139154 | 3011139154 | Uzinmedicare Co., Ltd. | 54, 56, 60 Dongtansandan 5-gil, Hwaseong-si Gyeonggi 18487 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain