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Mano4343W Wireless digital flat panel detector
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 03100132Model Venu1748V
by iRay Group
Identity
- Trade Name
- Mano4343W Wireless digital flat panel detector EUDAMEDWireless Digital Flat Panel Detector FDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Device Name
- Flat panel detector EUDAMEDMano4343W Wireless Digital Flat Panel Detector FDA UDI
- Model / Reference
- Venu1748V EUDAMED03100132 EUDAMEDMano4343W FDA UDI
- Description
- Mano4343W Wireless Digital Flat Panel Detector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970569090528 EUDAMEDFDA UDI
- Basic UDI-DI
- 697056909FPDTH EUDAMED
- Direct Marketing DI
- 06970569090528 EUDAMED
- FDA Product Code
- MQB FDA UDI
- EMDN Code
- Z11031180 SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Mano4343W Wireless digital flat panel detector by iRay Group — 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 | 697056909FPDTH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- iRay Group
- EUDAMED SRN
- CN-MF-000037606
- Authorised Representative
- iRay Europe GmbH DE-AR-000007525
Sources (2)
- EUDAMED 00009e39-eae3-44d7-9cd7-7def7337894f 61 fields · synced Jul 9, 2026
- FDA UDI cca6bc26-32e7-4268-80b4-2969ae7f6f77 33 fields · synced May 29, 2026