Identity
- Trade Name
- H5077M EUDAMED
- Device Name
- X-ray tube assenmly EUDAMED
- Model / Reference
- H5077M-0.1/0.3-49-V1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971564631389 EUDAMED
- Basic UDI-DI
- 697156463MXRTAUJ EUDAMED
- EMDN Code
- Z11039012 X-RAY TUBE ASSEMBLY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
H5077m by Hangzhou Kailong Medical Instruments Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697156463MXRTAUJ | Class IIb | Active |
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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 (1)
- EUDAMED 7da090d7-25e8-4cc8-a309-42e8ba7c5863 61 fields · synced Oct 6, 2026