Identity
- Trade Name
- H5077T EUDAMEDRADII FDA UDI
- Generic Name
- X-ray tube housing assembly, diagnostic FDA UDI
- Device Name
- X-ray tube assenmly EUDAMEDX-ray tube assembly is intended to be used as integrated part of compatible medical diagnostic X-ray equipment, for generating X-rays. FDA UDI
- Model / Reference
- H5077T-0.1-0.3-49-V1 EUDAMEDH5077T FDA UDI
- Description
- X-ray tube assembly is intended to be used as integrated part of compatible medical diagnostic X-ray equipment, for generating X-rays. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971564631396 EUDAMEDFDA UDI
- Basic UDI-DI
- 697156463MXRTAUJ EUDAMED
- FDA Product Code
- ITY FDA UDI
- EMDN Code
- Z11039012 X-RAY TUBE ASSEMBLY EUDAMED
- GMDN Term
- X-ray tube housing assembly, diagnostic FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1760 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The H5077T medical device is a Class IIb portable X-ray tube assembly used for diagnostic imaging, providing high-quality images of the human body. Its self-testing feature ensures accurate results without user intervention, while its compatibility with various X-ray machines supports seamless integration into existing medical facilities.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697156463MXRTAUJ | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Kailong Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000030241
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 569a4402-faa3-499f-977b-c99ffb4404b1 61 fields · synced Jun 23, 2026
- FDA UDI e24c4475-cc6e-46ba-b969-41901969e0cb 33 fields · synced May 30, 2026