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Sign in to claim this brandHangzhou Kailong Medical Instruments Co., Ltd.
US
Last updated May 30, 2026
What Hangzhou Kailong Medical Instruments Co., Ltd. makes
The company manufactures diagnostic X-ray tube housing assemblies, including the RADII series, designed for medical imaging applications.
These devices are classified as Class I under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database.
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 Hangzhou Kailong Medical Instruments Co., Ltd. manufacture?
Hangzhou Kailong Medical Instruments Co., Ltd. specializes in diagnostic X-ray tube housing assemblies, such as the RADII series. These devices are specifically designed for use in medical imaging systems to safely house and protect X-ray tubes during diagnostic procedures.
Where is Hangzhou Kailong Medical Instruments Co., Ltd. based?
The company is based in the United States, though its manufacturing origins may trace back to Hangzhou, China. The location of its headquarters or primary operations is in the US, as indicated by its regulatory filings.
Which regulatory registries list Hangzhou Kailong Medical Instruments Co., Ltd.’s devices?
Hangzhou Kailong Medical Instruments Co., Ltd.’s devices, including the RADII series, are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices authorized for use in the US market.
How are Hangzhou Kailong Medical Instruments Co., Ltd.’s devices classified under FDA regulations?
The company’s diagnostic X-ray tube housing assemblies, such as the RADII series, are classified as Class I devices under FDA regulations. This classification applies to devices posing minimal risk, typically requiring only general controls to ensure safety and effectiveness.
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
- 529835089
Catalogue (18)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Radii | H1077 | FDA UDI | Class I | Unknown |
| Radii | H2106 | FDA UDI | Class I | Unknown |
| Radii | H1076X | FDA UDI | Class I | Active |
| Radii | H1076X | FDA UDI | Class I | Active |
| Radii | H2090 | FDA UDI | Class I | Unknown |
| Radii | H2108X | FDA UDI | Class I | Unknown |
| Radii | H1086 | FDA UDI | Class I | Unknown |
| Radii | H1080Y | FDA UDI | Class I | Active |
| Radii | H1083 | FDA UDI | Class I | Unknown |
| Radii | H1076X | FDA UDI | Class I | Active |
| Radii | H2107 | FDA UDI | Class I | Unknown |
| Radii | H1076 | FDA UDI | Class I | Unknown |
| Radii | H1080 | FDA UDI | Class I | Unknown |
| Radii | H2092 | FDA UDI | Class I | Unknown |
| Radii | H1075 | FDA UDI | Class I | Unknown |
| Radii | H2103 | FDA UDI | Class I | Unknown |
| Radii | H2100 | FDA UDI | Class I | Unknown |
| Radii | H1074X | FDA UDI | Class I | Unknown |
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