Identity
- Trade Name
- Phosphor Plate Scanner EUDAMED
- Device Name
- Phosphor Plate Scanner EUDAMED
- Model / Reference
- DIGIREX PSP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719883022011 EUDAMED
- Basic UDI-DI
- 471988302SCANNERVU EUDAMED
- EMDN Code
- Z110601 LASER IMAGING SCANNER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Phosphor Plate Scanner by Dhef 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 | 471988302SCANNERVU | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dhef Inc.
- EUDAMED SRN
- TW-MF-000008480
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED fb8ba3e5-6174-4032-808d-ab9a2d72d1e5 61 fields · synced Jun 18, 2026