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Hisense
EUDAMEDFDA UDIClass I (EU MDR)
Ref HMD5G21SModel HMD2G21S,HMD3G21S,HMD5G21S
Identity
- Trade Name
- Hisense EUDAMEDFDA UDI
- Generic Name
- Image display unit, monochrome FDA UDI
- Device Name
- LCD Monitor EUDAMEDFDA UDI
- Model / Reference
- HMD2G21S,HMD3G21S,HMD5G21S EUDAMEDHMD5G21S EUDAMEDFDA UDI
- Description
- LCD Monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06933741400874 EUDAMED06933741405244 FDA UDI
- Basic UDI-DI
- 69337414XSQ001V6 EUDAMED
- 510(k) Number
- K221567 FDA UDI
- FDA Product Code
- PGY 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 UDI
- Regulation Number
- 892.2050 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 Equipment Co., Ltd. — Class I — 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 | 69337414XSQ001V6 | 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 (2)
- EUDAMED 248d703c-164e-4595-8b47-3078c1d67b67 61 fields · synced Oct 6, 2026
- FDA UDI 72384c3e-d4b9-449e-b739-1d4eb167428c 34 fields · synced May 29, 2026