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Sign in to claim this brandWuhan Huchuang Union Technology Co., Ltd.
US
Last updated May 23, 2026
What Wuhan Huchuang Union Technology Co., Ltd. makes
The company produces assisted reproduction procedure dishes, including the Metiec line, designed for use in in vitro fertilization (IVF) and related reproductive technologies. These devices are intended for handling gametes, embryos, and reproductive cells in controlled laboratory settings.
The portfolio includes Class I and Class II devices, with regulatory submissions filed under FDA 510(k) and UDI requirements. The company’s products are listed in the United States, adhering to FDA regulatory pathways for medical devices.
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 Wuhan Huchuang Union Technology Co., Ltd. manufacture?
Wuhan Huchuang Union Technology Co., Ltd. specializes in assisted reproduction procedure dishes, specifically the Metiec line. These devices are engineered for use in in vitro fertilization (IVF) and related reproductive technologies, where they facilitate the handling of gametes, embryos, and reproductive cells in laboratory environments. The focus is on sterile, controlled conditions critical for reproductive procedures.
Where is Wuhan Huchuang Union Technology Co., Ltd. based, and where are its devices listed?
The company is based in the United States. Its devices are listed in the FDA’s regulatory systems, including submissions under the 510(k) pathway and compliance with Unique Device Identifier (UDI) requirements. This indicates the company’s adherence to U.S. regulatory frameworks for medical devices.
How are the devices manufactured by Wuhan Huchuang Union Technology Co., Ltd. classified under FDA regulations?
The company’s devices fall into two primary FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require less regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and submission requirements for each device.
Which regulatory registries or databases list the devices produced by Wuhan Huchuang Union Technology Co., Ltd.?
The company’s devices are listed in the FDA’s 510(k) premarket notification database and comply with UDI requirements. These registries ensure transparency and traceability of medical devices in the U.S., allowing healthcare providers, regulators, and other stakeholders to access critical information about the devices’ regulatory status and compliance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 554404052
Catalogue (15)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Metiec | MC2002 10pcs/bag | FDA UDI | Class II | Active |
| Metiec | MC2010 10pcs/bag | FDA UDI | Class II | Active |
| Metiec | MC2007 10pcs/bag | FDA UDI | Class II | Active |
| Metiec | TLS301 | FDA UDI | Class I | Active |
| Metiec | MC2015 10pcs/bag | FDA UDI | Class II | Active |
| Metiec | MC2003 10pcs/bag | FDA UDI | Class II | Active |
| Metiec | MC2001 10pcs/bag | FDA UDI | Class II | Active |
| Metiec | MC2006 10pcs/bag | FDA UDI | Class II | Active |
| Metiec | MC2008 10pcs/bag | FDA UDI | Class II | Active |
| Metiec | MC2014 10pcs/bag | FDA UDI | Class II | Active |
| Metiec | MC2004 1pc/bag | FDA UDI | Class II | Active |
| Metiec | MC2004 1pc/bag | FDA UDI | Class II | Active |
| Metiec | D-CK1000 | FDA UDI | Class II | Active |
| Metiec | MC2011 10pcs/bag | FDA UDI | Class II | Active |
| Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) | K232493 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Wuhan Huchuang Union Technology Co., Ltd. Wuhan Hubei · CN FEI 3023235140