Identity
- Trade Name
- ISOCube Phantom EUDAMED
- Device Name
- SDVP Phantom EUDAMED
- Model / Reference
- 91640 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850019946710 EUDAMED
- Basic UDI-DI
- 0850019946SDVPHANTOMNS 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
Category: Multi-modality therapeutic radiation phantom, test object
ISOCube Phantom by Standard Imaging, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0850019946SDVPHANTOMNS | 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 3ac7720c-4d25-4cf4-b5e4-462343b2306f 61 fields · synced Jun 18, 2026