Identity
- Trade Name
- MVR460 EUDAMEDMVR FDA UDI
- Generic Name
- Medical video image recorder FDA UDI
- Device Name
- MVR Lite EUDAMEDMedical Video Recorder FDA UDI
- Model / Reference
- MVR400 EUDAMEDMVR460 EUDAMEDFDA UDI
- Description
- Medical Video Recorder FDA UDI
Identifiers
- Catalog Number
- MVR460 FDA UDI
- Primary DI / UDI-DI
- 00859151005071 EUDAMEDFDA UDI
- Basic UDI-DI
- 0859151005MVR8K EUDAMED
- FDA Product Code
- LMD FDA UDI
- EMDN Code
- Z119014 VIDEO RECORDERS FOR BIOIMAGES EUDAMED
- GMDN Term
- Medical video image recorder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.2020 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
No
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
Mvr460 by Medicapture, Inc. — 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 | 0859151005MVR8K | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MediCapture, Inc.
- EUDAMED SRN
- US-MF-000013680
- Authorised Representative
- MEDICAPTURE EUROPE B.V. NL-AR-000018862
Sources (2)
- EUDAMED 617d69ca-c99e-4d64-874d-6ab1d3efadf7 61 fields · synced Jun 18, 2026
- FDA UDI a64c06b6-46bd-4031-b293-c13aa269e0d3 34 fields · synced May 30, 2026