Identity
- Trade Name
- SONY EUDAMEDFDA UDI
- Generic Name
- Medical video image recorder FDA UDI
- Device Name
- 3D HD Video Recorder, 4K3D Video Recorder, HD Video Recorder EUDAMED4K3D VIDEO RECORDER FDA UDI
- Model / Reference
- HVO-4000MT EUDAMEDFDA UDI
- Description
- 4K3D VIDEO RECORDER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04548736118881 EUDAMEDFDA UDI
- Basic UDI-DI
- 4901780RecorderQ4 EUDAMED
- FDA Product Code
- LMB FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Medical video image recorder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.2010 FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Device sterilization/disinfection container, reusable
Sony by Sony Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 4901780RecorderQ4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sony Corporation
- EUDAMED SRN
- JP-MF-000014553
- Authorised Representative
- Sony Belgium, bijkantoor van Sony Europe B.V. BE-AR-000007876
Sources (2)
- EUDAMED b9757956-b8f6-4530-8a15-bc90760b8e76 61 fields · synced Jul 9, 2026
- FDA UDI a9a23aa6-cae7-4d11-a3d3-08a31b82310a 33 fields · synced May 30, 2026