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Hisense
EUDAMEDClass I (EU MDR)
Ref HME8C55UModel HME2C26,HME8C32,HME8C55E,HME8C55S,HME8C27,HME8C32E,HME8C55U
Identity
- Trade Name
- Hisense EUDAMED
- Device Name
- LCD Monitor EUDAMED
- Model / Reference
- HME2C26,HME8C32,HME8C55E,HME8C55S,HME8C27,HME8C32E,HME8C55U EUDAMEDHME8C55U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933741405169 EUDAMED
- Basic UDI-DI
- 69337414XSQ002V8 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I 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 Equipment Co., Ltd. — Class I — 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 | 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 (1)
- EUDAMED 183593c1-0704-4a4c-b2ef-8fbeb7afc2a9 61 fields · synced May 23, 2026