MVR450
Part of a family of 7 devices: see the family page
Ref MVR450
MVR450 is a Class I device made by Medicapture, Inc., registered in EUDAMED on 8 Jan 2025 (Basic UDI-DI 0859151005MVR8K) and listed in FDA GUDID since 27 Jan 2025 (UDI-DI 00859151005088), active as of 23 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number00859151005088 | Date27 Jan 2025 | StatusListed |
| European Union | CE/MDR EUDAMED | Number0859151005MVR8K 00859151005088 | Date8 Jan 2025 | StatusActive |
Official records
- EUDAMED public site 0859151005MVR8K
- AccessGUDID record 00859151005088
Across registries
- EUDAMED Basic UDI-DI 0859151005MVR8K registered 8 Jan 2025 Active
- FDA GUDID UDI-DI 00859151005088 listed 27 Jan 2025 Listed
Timeline
- Registered EUDAMED 0859151005MVR8K
- Listed FDA GUDID 00859151005088
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- MVR450 EUDAMEDMvr GUDID
- Generic name
- Medical video image recorder
- Model / Ref / Catalog
- MVR450
- Primary DI / UDI-DI
- 00859151005088
- Basic UDI-DI
- 0859151005MVR8K
- FDA product code
- LMD
- EMDN code
- Z119014 Video recorders for bioimages
- GMDN term
- Medical video image recorder
- Device class
- Class I
- Regulation number
- 892.2020
- EU registration type
- Standard device
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Manufacturer details
- EUDAMED SRN
- US-MF-000013680
- Authorised representative
- MEDICAPTURE EUROPE B.V. NL-AR-000018862
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