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Hisense
EUDAMEDClass I (EU MDR)
Ref HME8C32EModel 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 EUDAMEDHME8C32E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933741405152 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
Category: Device sterilization/disinfection container, reusable
Hisense by Qingdao Hisense Medical Equipment Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 52ca7d0f-13dd-4fcf-bcd4-e747c5271f2a 61 fields · synced May 23, 2026