← Back to catalogue
Flat Panel Digital X-ray Detector
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref EXPD 3643U1Model EXPD 129P
Identity
- Trade Name
- EXPD-N series FDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Device Name
- Flat Panel Digital X-ray Detector EUDAMED
- Model / Reference
- EXPD 129P EUDAMEDEXPD 3643U1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800018430705 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000184DGXXXXXXXXRV EUDAMED
- Direct Marketing DI
- 08800018430705 EUDAMED
- 510(k) Number
- K243443 FDA UDI
- FDA Product Code
- MQB FDA UDI
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
- GMDN Term
- Indirect flat panel x-ray detector FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Flat Panel Digital X-ray Detector by DRTECH Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000184DGXXXXXXXXRV | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DRTECH Corporation
- EUDAMED SRN
- KR-MF-000012441
- Authorised Representative
- DRTECH Europe GmbH DE-AR-000011974
Sources (2)
- EUDAMED a473cd85-8f09-454b-8537-7e0d538ae106 61 fields · synced Jul 27, 2026
- FDA UDI 4e2b0568-cec9-4967-9689-60b22b8a7a95 33 fields · synced May 30, 2026