LUCY EA Phantom
Ref 91600
LUCY EA Phantom (91600) is a Class I device made by Standard Imaging Inc., registered in EUDAMED on 19 May 2026 (Basic UDI-DI 0850019946LUCYPHANTOMP4), active as of 8 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0850019946LUCYPHANTOMP4 00850019946635 | Date19 May 2026 | StatusActive |
Official records
- EUDAMED public site 0850019946LUCYPHANTOMP4
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- LUCY Phantom
- Model / reference
- 91600
- Primary DI / UDI-DI
- 00850019946635
- Basic UDI-DI
- 0850019946LUCYPHANTOMP4
- EMDN code
- Z11019080 Various radiotherapy and radiosurgery instruments - hardware accessories
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- US-MF-000009855
- Authorised representative
- Hoff & Lowendahl AB SE-AR-000001888
Similar devices in this category
Other devices filed under VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES.