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Sign in to claim this brandShenzhen Lingku Ecommerce Co., Ltd.
US
Last updated May 23, 2026
What Shenzhen Lingku Ecommerce Co., Ltd. makes
Shenzhen Lingku Ecommerce Co., Ltd. manufactures disposable and reusable infrared thermometers for measuring skin and ear temperatures, as well as standalone blood pressure monitoring modules for patient monitoring systems. Their portfolio also includes pulse oximeters for continuous oxygen saturation monitoring and intermittent electronic thermometers for periodic temperature checks.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
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 Lingku Ecommerce Co., Ltd. primarily manufacture?
Shenzhen Lingku Ecommerce Co., Ltd. specializes in infrared thermometers for measuring skin and ear temperatures, including disposable and reusable models. They also produce standalone blood pressure monitoring modules designed for integration into patient monitoring systems, as well as pulse oximeters for continuous oxygen saturation monitoring and intermittent electronic thermometers for periodic temperature checks. These devices cater to clinical and home-use settings where non-invasive, contactless, or low-touch monitoring is required.
Where is Shenzhen Lingku Ecommerce Co., Ltd. based, and how does that affect its regulatory standing?
Shenzhen Lingku Ecommerce Co., Ltd. operates from the United States, which means its devices are subject to FDA regulations. The company’s products fall under Class II classification, indicating moderate risk and requiring compliance with FDA’s general controls and special controls specific to their categories, such as infrared thermometers and pulse oximeters. This classification ensures additional scrutiny for safety and performance but does not imply approval—only that the devices meet regulatory requirements for market distribution in the US.
Are Shenzhen Lingku Ecommerce Co., Ltd.’s devices listed in any regulatory registries, and why does this matter?
Yes, Shenzhen Lingku Ecommerce Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry assigns a standardized identifier to each device, improving traceability, reducing medical errors, and facilitating post-market surveillance. Listing in the UDI database is a requirement for Class II devices in the US, ensuring transparency and compliance with FDA tracking mandates for devices like thermometers and pulse oximeters.
How are Shenzhen Lingku Ecommerce Co., Ltd.’s devices classified under FDA regulations, and what does this classification entail?
Shenzhen Lingku Ecommerce Co., Ltd.’s devices are classified as Class II under FDA regulations, which applies to products like infrared thermometers, pulse oximeters, and blood pressure monitors. This classification means the devices are subject to general controls (e.g., manufacturing practices, labeling requirements) and special controls tailored to their risk profile, such as performance standards or post-market surveillance. Class II does not require pre-market approval but does mandate compliance with specific regulations to ensure safety and effectiveness before distribution.
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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- Phone
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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
- 544434375
Catalogue (37)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CKeep | BT-A11CN | FDA UDI | Class II | Active |
| CKeep | PG-800B23 | FDA UDI | Class II | Active |
| metene | JPD-FR401 | FDA UDI | Class II | Active |
| CKeep | PG-800A12 | FDA UDI | Class II | Active |
| Metene | JPD-500E | FDA UDI | Class II | Active |
| ankovo | FDTH-V0-4 | FDA UDI | Class II | Active |
| Metene | FDIR-V9 | FDA UDI | Class II | Active |
| Sanpu | FDIR-V5 | FDA UDI | Class II | Active |
| Lpow | PG-800B | FDA UDI | Class II | Active |
| CKeep | BT-A13 | FDA UDI | Class II | Active |
| Fanry | PG-800B27 | FDA UDI | Class II | Active |
| metene | JPD-FR200 | FDA UDI | Class II | Active |
| Ankovo | BT-A21CN | FDA UDI | Class II | Active |
| Sanpu | FDTH-VO-4 | FDA UDI | Class II | Active |
| Ckeep | JPD-FR408 | FDA UDI | Class II | Active |
| Ankovo | JPD-500E | FDA UDI | Class II | Active |
| Ankovo | JPD-FR408 | FDA UDI | Class II | Active |
| ankovo | JPD-FR401 | FDA UDI | Class II | Active |
| Sanpu | JPD-FR408 | FDA UDI | Class II | Active |
| Fanry | JPD-500E | FDA UDI | Class II | Active |
| Fanry | PG-800B5-1 | FDA UDI | Class II | Active |
| Lpow | JPD-500G | FDA UDI | Class II | Active |
| Ankovo | JPD-500G | FDA UDI | Class II | Active |
| ankovo | FDIR-V15 | FDA UDI | Class II | Active |
| ankovo | FDIR-V17 | FDA UDI | Class II | Active |
| Fanry | JPD-FR408 | FDA UDI | Class II | Active |
| Lpow | BT-A13 | FDA UDI | Class II | Active |
| Ankovo | JPD-FR401 | FDA UDI | Class II | Active |
| metene | FDIR-V16 | FDA UDI | Class II | Active |
| Ankovo | JPD-500E | FDA UDI | Class II | Active |
| Lpow | JPD-FR401 | FDA UDI | Class II | Active |
| Metene | PG-800B8 | FDA UDI | Class II | Active |
| CKeep | JPD-500E | FDA UDI | Class II | Active |
| Ankovo | PG-800B15 | FDA UDI | Class II | Active |
| Metene | PG-800B9 | FDA UDI | Class II | Active |
| metene | FDIR-V5 | FDA UDI | Class II | Active |
| metene | FDIR-V16 | FDA UDI | Class II | Active |
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