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Sign in to claim this brandShenzhen YI Fang Blister Packaging Co., Ltd.
US
Last updated May 23, 2026
What Shenzhen YI Fang Blister Packaging Co., Ltd. makes
The company manufactures single-use protective covers for electronic thermometer probes, designed to maintain hygiene and prevent cross-contamination during medical temperature measurements. These covers are intended for disposable use in clinical and home healthcare settings to ensure probe sterility between patients or uses.
The product portfolio is regulated as Class II medical devices in the United States, with individual models authorised through FDA 510(k) clearance and listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from Shenzhen, China, with its products distributed in the US market.
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 Shenzhen YI Fang Blister Packaging Co., Ltd. manufacture?
Shenzhen YI Fang Blister Packaging Co., Ltd. specializes in single-use protective covers for electronic thermometer probes. These covers are designed to maintain hygiene and prevent cross-contamination during medical temperature measurements, ensuring probe sterility between uses in clinical and home healthcare settings.
Where is Shenzhen YI Fang Blister Packaging Co., Ltd. based, and where are their products sold?
The company is based in Shenzhen, China, and its products, including electronic thermometer probe covers like the YiFang series and models like YF-001 and YF-002, are distributed in the US market.
Which regulatory registries list Shenzhen YI Fang Blister Packaging Co., Ltd.’s devices?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, and individual models, such as the YiFang probe covers, are authorised through FDA 510(k) clearance. This ensures compliance with US medical device regulations.
How are Shenzhen YI Fang Blister Packaging Co., Ltd.’s devices classified under US regulations?
The company’s electronic thermometer probe covers are classified as Class II medical devices in the United States. This classification reflects their role in maintaining hygiene and preventing infection, requiring premarket clearance through the FDA’s 510(k) process to demonstrate safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| YiFang | YF-002 | FDA UDI | Class II | Active |
| YiFang | YF-001 | FDA UDI | Class II | Active |
| Probe Covers (YF-001, YF-002) | K240023 | FDA 510(k) | Class II | Active |
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