Standard Imaging Exradin D1H Diode Detector
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Exradin D1H Diode EUDAMEDStandard Imaging Exradin D1H Diode Detector FDA UDI
- Generic Name
- Radiation condenser R-meter FDA UDI
- Device Name
- Exradin Scanning Diode EUDAMEDStandard Imaging Exradin D1H Diodes are diode based radiation detectors for use in small field dosimetry FDA UDI
- Model / Reference
- 92741 EUDAMEDFDA UDI
- Description
- Standard Imaging Exradin D1H Diodes are diode based radiation detectors for use in small field dosimetry FDA UDI
Identifiers
- Catalog Number
- 92741 FDA UDI
- Primary DI / UDI-DI
- 00850019946475 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850019946EXRADINDIODEAY EUDAMED
- FDA Product Code
- LHO FDA UDI
- EMDN Code
- Z11019099 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Radiation condenser R-meter FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1940 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Radiation condenser R-meter
Standard Imaging Exradin D1H Diode Detector by Standard Imaging, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Standard Imaging, Inc.
Sources (2)
- FDA UDI 39ca9914-d513-4a90-ac78-d6139af3e389 34 fields · synced Jun 19, 2026
- EUDAMED 46918c11-a611-487f-a9f4-85abfc7b992b 61 fields · synced Jun 19, 2026