Hisense
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Hisense EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- LCD Monitor EUDAMEDUltrasound Diagnostic System EUDAMEDFDA UDI
- Model / Reference
- HME2C26,HME8C32,HME8C55E,HME8C55S,HME8C27,HME8C32E,HME8C55U EUDAMEDHME8C55E EUDAMEDHD60 Series EUDAMEDHD61 EUDAMEDFDA UDI
- Description
- Ultrasound Diagnostic System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06933741400881 EUDAMED06933741401154 EUDAMEDFDA UDI
- Basic UDI-DI
- 69337414XSQ002V8 EUDAMED69337414UltrasoundQU EUDAMED
- 510(k) Number
- K213862 FDA UDI
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMEDZ11040101 INTERNAL ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass 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
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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Device sterilization/disinfection container, reusable
Hisense by Qingdao Hisense Medical Equipment Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69337414XSQ002V8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Qingdao Hisense Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000007334
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 18413554-e2fe-4bd0-baea-092c08e7b1c8 61 fields · synced Oct 6, 2026
- EUDAMED a5479e1e-869a-4f40-b08f-c5e615e93d8d 61 fields · synced May 17, 2026
- FDA UDI ed2eceb9-6895-4fad-a4a8-6d1e4cac2cbe 34 fields · synced May 30, 2026