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Sign in to claim this brandWhat Uzinmedicare Co., Ltd. makes
Uzinmedicare Co., Ltd. manufactures reusable breast pump support kits, electric and manual breast pumps, and reusable electrical connection cables for medical devices. Their products include the Spectra series, designed for lactation support.
The company’s devices are regulated under FDA 510(k) and UDI requirements, with classifications spanning Class I and Class II. Their products are listed in the FDA’s regulatory databases.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Uzinmedicare Co., Ltd. manufacture?
Uzinmedicare Co., Ltd. specializes in lactation support devices, including reusable breast pump support kits, electric breast pumps, manual breast pumps, and reusable electrical connection cables for medical devices. Their product line primarily features the Spectra series, which covers these categories.
Where is Uzinmedicare Co., Ltd. based, and how does that affect its devices?
Uzinmedicare Co., Ltd. is based in the United States, meaning their devices fall under FDA regulatory oversight. This includes compliance with FDA requirements such as 510(k) premarket notifications and Unique Device Identifier (UDI) regulations.
Which regulatory databases list Uzinmedicare Co., Ltd.’s devices?
Uzinmedicare Co., Ltd.’s devices are included in the FDA’s regulatory databases, specifically under the 510(k) premarket notification program and the UDI system. These listings reflect their compliance with FDA requirements for medical devices.
How are Uzinmedicare Co., Ltd.’s devices classified under FDA regulations?
Uzinmedicare Co., Ltd.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness.
Why are some of Uzinmedicare Co., Ltd.’s devices listed under both 510(k) and UDI requirements?
The FDA requires 510(k) premarket notifications for most medical devices to demonstrate substantial equivalence to a predicate device, ensuring they meet safety and performance standards. The UDI system assigns unique identifiers to devices to improve tracking, reduce medical errors, and enhance post-market surveillance. Both requirements apply to Uzinmedicare’s devices to ensure regulatory compliance and traceability.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- uzinmedical.co.kr
- —
- —
- [email protected]
- Phone
- +821053081195
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 688451947
Catalogue (113)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Spectra | Spectra accessory (24mm shield set) | FDA UDI | Class II | Active |
| Spectra | Spectra Synergy Gold | FDA UDI | Class II | Active |
| Spectra | Spectra accessory (20mm shield set) | FDA UDI | Class II | Active |
| Spectra | Spectra accessory (DEW350 Bagic Accessory Kit) | FDA UDI | Class II | Active |
| Synergy Gold (SG) Portable (Models MM011450 and MM011460) | K210124 | FDA 510(k) | Class II | Active |
| Spectra Cashmere | K191208 | FDA 510(k) | Class II | Active |
| Spectra S1 Pro; Spectra S2 Pro | K251423 | FDA 510(k) | Class II | Active |
| Spectra Platinum | K251932 | FDA 510(k) | Class II | Active |
| Spectra Series Breast Pump | K093145 | FDA 510(k) | Class II | Active |
| Spectra S3 Plus | K181784 | FDA 510(k) | Class II | Active |
| Spectra S1Plus and Spectra S2 Plus | K150476 | FDA 510(k) | Class II | Active |
| SPECTRA Wearable 2 | K250208 | FDA 510(k) | Class II | Active |
| Spectra Wearable | K220926 | FDA 510(k) | Class II | Active |
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