Identity
- Trade Name
- EXPD 2121P EUDAMED
- Device Name
- Flat Panel Digital X-ray Detector EUDAMED
- Model / Reference
- EXPD 129P EUDAMEDEXPD 2121P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800018407707 EUDAMED
- Basic UDI-DI
- 88000184DGXXXXXXXXRV EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIa 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
Expd 2121p by DRTECH Corporation — Class IIa — 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 | 88000184DGXXXXXXXXRV | Class IIa | Active |
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Manufacturer
- Manufacturer
- DRTECH Corporation
- EUDAMED SRN
- KR-MF-000012441
- Authorised Representative
- DRTECH Europe GmbH DE-AR-000011974
Sources (1)
- EUDAMED 16bcb206-f37b-4467-bcc6-46980d3373fb 61 fields · synced Jun 18, 2026