Identity
- Trade Name
- Model 4 Phantom EUDAMED
- Device Name
- Model 4 Phantom EUDAMED
- Model / Reference
- Model 4 Phantom EUDAMEDB052PHCTM40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B052PHCTM40 EUDAMED
- Basic UDI-DI
- ++B052PHANTOMTU EUDAMED
- EMDN Code
- Z11900180 BONE DENSITOMETRY SYSTEMS - 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
Model 4 Phantom by Mindways Software, 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 | ++B052PHANTOMTU | Class I | Active |
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Manufacturer
- Manufacturer
- Mindways Software, Inc.
- EUDAMED SRN
- US-MF-000012877
- Authorised Representative
- Johner Medical GmbH DE-AR-000011832
Sources (1)
- EUDAMED 88b817c0-d07d-4f0f-9652-a4a05dfff2a5 61 fields · synced Jun 18, 2026