Model 4 Phantom
Ref B052PHCTM40Model Model 4 Phantom
Model 4 Phantom (B052PHCTM40) is a Class I device made by Mindways Software, Inc., registered in EUDAMED on 29 Sep 2025 (Basic UDI-DI ++B052PHANTOMTU), active as of 24 Oct 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 | Number++B052PHANTOMTU +B052PHCTM40 | Date29 Sep 2025 | StatusActive |
Official records
- EUDAMED public site ++B052PHANTOMTU
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- Withdrawn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
- Model / reference
- Model 4 Phantom, B052PHCTM40
- Primary DI / UDI-DI
- +B052PHCTM40
- Basic UDI-DI
- ++B052PHANTOMTU
- EMDN code
- Z11900180 Bone densitometry systems - hardware accessories
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- US-MF-000012877
- Authorised representative
- Johner Medical GmbH DE-AR-000011832
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