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Hisense
EUDAMEDClass IIa (EU MDR)
Ref HD78ProModel HD 20 series to HD 60 series,HD 80 series,H7 and Aisense series
Identity
- Trade Name
- Hisense EUDAMED
- Device Name
- Ultrasound diagnostic systems HD 20 series to HD 60 series,Ultrasound diagnostic systems HD 80 series,Ultrasound diagnostic systems H7 and Aisense series EUDAMED
- Model / Reference
- HD 20 series to HD 60 series,HD 80 series,H7 and Aisense series EUDAMEDHD78Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978311951974 EUDAMED
- Basic UDI-DI
- 697831195Ultrasound9F EUDAMED
- EMDN Code
- Z11040101 INTERNAL ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Hisense by Qingdao Hisense Medical Co., Ltd. — Class IIa — 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 | 697831195Ultrasound9F | Class IIa | Active |
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Manufacturer
- Manufacturer
- Qingdao Hisense Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000047224
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED b944e273-3420-4626-9e5d-fba96d88f361 61 fields · synced Oct 5, 2026