Identity
- Trade Name
- ClearRead Xray Detect EUDAMEDFDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- ClearRead Xray Detect EUDAMEDClearRead Xray Server Detect FDA UDI
- Model / Reference
- 7.0.0 EUDAMEDFDA UDI
- Description
- ClearRead Xray Server Detect FDA UDI
Identifiers
- Primary DI / UDI-DI
- M722X25122C250640 EUDAMEDFDA UDI
- Basic UDI-DI
- ++M722XCF4 EUDAMED
- Direct Marketing DI
- M722X25122C250640 EUDAMED
- FDA Product Code
- MYN FDA UDI
- EMDN Code
- Z119092 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2070 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
ClearRead Xray Detect by Riverain Technologies, Inc. — 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 | ++M722XCF4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Riverain Technologies, Inc.
- EUDAMED SRN
- US-MF-000003233
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 801abf51-173b-4d8b-90e1-b38b49b081e8 61 fields · synced Jul 18, 2026
- FDA UDI 752ca5e6-8abf-49a0-bbf8-39f3aa29aa09 33 fields · synced May 30, 2026