Medxr
by MED.e.Com
Ref 7.0Model MEDXRAY
Medxr (7.0) is a Class IIa device made by Med.e.com, registered in EUDAMED on 24 May 2023 (Basic UDI-DI 3665587ACQUISITION00001YU) with CE/MDR certificate FR25/00000027 valid until 20 Jan 2030, active as of 22 Oct 2026.
Active
CE MDR
Valid until
20 Jan 2030
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberFR25/00000027 | Date29 Jan 2025 | StatusActive |
Official records
- EUDAMED public site 3665587ACQUISITION00001YU
Certificates
- FR25/00000027 Active
Quality management system EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 29 Jan 2025
- Expires
- 20 Jan 2030
- Reason
- Mnf ar change
Timeline
- Registered EUDAMED 3665587ACQUISITION00001YU
- Certificate issued EUDAMED FR25/00000027
- Certificate expires EUDAMED FR25/00000027
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Medxray
- Model / reference
- MEDXRAY, 7.0
- Primary DI / UDI-DI
- 03665587000125
- Basic UDI-DI
- 3665587ACQUISITION00001YU
- Direct marketing DI
- 03665587000125
- EMDN code
- Z11069092 Various digital bioimaging management instruments - medical device software
- Device class
- Class IIa
- Special device type
- Software
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000003036
Similar devices in this category
Other devices filed under VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE.
- QP-Brain® 1.0 by QUIBIM S.L.
- Lumi Referenced 01 by Augmedit B.V.
- Brainlab Elements Contouring, 5.0 04056481145880 by Brainlab SE
- CAD/CAM Software 6820893 by SIRONA Dental Systems GmbH
- BriefCase-Quantification (BC-QTF) by AIDOC MEDICAL LTD
- DS Core Detect 04262352357935 by Zetta25 AG
- Lunit INSIGHT MMG 124012 by Lunit Inc.
- CAD/CAM Software 6834670 by SIRONA Dental Systems GmbH
- PIUR tUS inside 0202 by piur imaging GmbH
- AW Server (version: 3.2) 5719780 by GE Medical Systems SCS