Hisense
EUDAMEDFDA 510(k)FDA UDIClass I (EU MDR)
Identity
- Trade Name
- Hisense EUDAMEDFDA UDI
- Generic Name
- Image display unit, monochrome FDA UDI
- Device Name
- LCD Monitor EUDAMEDFDA UDI
- Model / Reference
- HME2C26,HME8C32,HME8C55E,HME8C55S,HME8C27,HME8C32E,HME8C55U EUDAMEDHME8C32 EUDAMEDHME2C26 EUDAMEDNA EUDAMEDHMD3G21S EUDAMEDFDA UDIHMD2G21S,HMD3G21S,HMD5G21S EUDAMED
- Description
- LCD Monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06933741400713 EUDAMED06933741405015 EUDAMED06933741400065 EUDAMED06933741400843 EUDAMED06933741405367 FDA UDI
- Basic UDI-DI
- 69337414XSQ002V8 EUDAMED69337414XSQ001V6 EUDAMED
- Direct Marketing DI
- 06933741400065 EUDAMED
- FDA Product Code
- PGY FDA 510(k)FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Image display unit, monochrome FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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 — FDA_510K, MDR — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222208 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69337414XSQ002V8 | Class I | Active |
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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 (7)
- EUDAMED c062d2b9-7769-488e-9654-5a8bd9eb3188 61 fields · synced Oct 6, 2026
- EUDAMED 52e2c65e-ed65-46ce-8b53-fd6bceb0ad76 61 fields · synced May 18, 2026
- EUDAMED adcf9efd-f093-452e-b617-e83e6d975447 61 fields · synced May 18, 2026
- FDA 510(k) K222208 24 fields · synced May 18, 2026
- FDA UDI ddd30c44-e975-42a1-b2f3-c78896852b3c 34 fields · synced May 30, 2026
- EUDAMED adcf9efd-f093-452e-b617-e83e6d975447-1 61 fields · synced Jul 14, 2026
- EUDAMED 5e5fceb9-7d92-4b95-9921-79e3075279a6 61 fields · synced Jul 15, 2026