Identity
- Trade Name
- LUCY EA Phantom EUDAMED
- Device Name
- LUCY Phantom EUDAMED
- Model / Reference
- 91600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850019946635 EUDAMED
- Basic UDI-DI
- 0850019946LUCYPHANTOMP4 EUDAMED
- EMDN Code
- Z11019080 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
LUCY EA Phantom by Standard Imaging, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850019946LUCYPHANTOMP4 | Class I | Active |
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Manufacturer
- Manufacturer
- Standard Imaging, Inc.
- EUDAMED SRN
- US-MF-000009855
- Authorised Representative
- Hoff & Lowendahl AB SE-AR-000001888
Sources (1)
- EUDAMED 7d35143a-fdf0-4beb-ad5f-79c480be44a7 61 fields · synced Jul 25, 2026