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Hisense
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref HD42EModel HD 20 series to HD 60 series,HD 80 series,H7 and Aisense series
Identity
- Trade Name
- Hisense EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- 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 EUDAMEDUltrasound Diagnostic System FDA UDI
- Model / Reference
- HD 20 series to HD 60 series,HD 80 series,H7 and Aisense series EUDAMEDHD42E EUDAMEDFDA UDI
- Description
- Ultrasound Diagnostic System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06978311950724 EUDAMED06933741401253 FDA UDI
- Basic UDI-DI
- 697831195Ultrasound9F EUDAMED
- 510(k) Number
- K213862 FDA UDI
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDI
- EMDN Code
- Z11040101 INTERNAL ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1560 FDA UDI892.1570 FDA UDI
- Market of Registration
- Germany 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Hisense by Qingdao Hisense Medical Co., Ltd. — Class IIa — 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 | 697831195Ultrasound9F | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED a7645564-9225-496e-8b4b-1f03a1908dc0 61 fields · synced Oct 5, 2026
- FDA UDI b9d6b125-4161-4a52-8a9e-d4ad7af9dee5 34 fields · synced May 30, 2026