Identity
- Trade Name
- H1080Y 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
- H1080Y-0.6 1.2-150H（V2） EUDAMEDH1080Y 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
- 06971564631198 EUDAMEDFDA UDI
- Basic UDI-DI
- 697156463XRTATL 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
H1080y by Hangzhou Kailong Medical Instruments Co., Ltd. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697156463XRTATL | 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 bacbaacc-c303-43e2-8027-8b4d8deb4bc8 61 fields · synced Jun 18, 2026
- FDA UDI 6cfe81f7-18e1-41e2-b504-b733a3c0a1d3 33 fields · synced May 30, 2026