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Digital Medical X-ray Radiographic System
EUDAMEDClass IIb (EU MDR)
Ref DTP580B-3
Identity
- Device Name
- Digital Medical X-ray Radiographic System EUDAMED
- Model / Reference
- DTP580B-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972764130252 EUDAMED
- Basic UDI-DI
- 697276413AG001BF EUDAMEDB-06972764130252 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Stationary basic diagnostic x-ray system, digital
Digital Medical X-ray Radiographic System by Shenzhen Angell Technology Co., Ltd — Class IIb — MDD, 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/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697276413AG001BF | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697276413AG001BF | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Angell Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000023030
- Authorised Representative
- Angell Technology GmbH DE-AR-000037290
Sources (2)
- EUDAMED d3dc6fa0-6f34-413f-9a9e-a8d039ef8c23 61 fields · synced Aug 2, 2026
- EUDAMED 8e126ef5-5b75-4a79-8beb-bef81c123370 61 fields · synced May 16, 2026