Identity
- Trade Name
- MVR EUDAMEDFDA UDI
- Generic Name
- Medical video image recorder FDA UDI
- Device Name
- MVR Lite EUDAMEDMVR420 FDA UDI
- Model / Reference
- MVR400 EUDAMEDMVR420 EUDAMEDFDA UDI
- Description
- MVR420 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859151005132 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
Mvr 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 94a823f0-2913-47a1-bb82-4e5f56c05eea 61 fields · synced May 29, 2026
- FDA UDI e7ecffa3-c9cb-49bc-83b5-49c89ae347cd 33 fields · synced May 27, 2026