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Standard Imaging Exradin W1 Scintillator
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 92739
Identity
- Trade Name
- Exradin W1 Scintillator EUDAMEDStandard Imaging Exradin W1 Scintillator FDA UDI
- Generic Name
- Radiation condenser R-meter FDA UDI
- Device Name
- Exradin Scintillator EUDAMEDStandard Imaging Exradin W1 Scintillator is a plastic scintillating fiber-based detector designed for highly accurate measurement of small radiotherapy fields used in patient plan verification and machine commissioning and QA procedures. FDA UDI
- Model / Reference
- 92739 EUDAMEDFDA UDI
- Description
- Standard Imaging Exradin W1 Scintillator is a plastic scintillating fiber-based detector designed for highly accurate measurement of small radiotherapy fields used in patient plan verification and machine commissioning and QA procedures. FDA UDI
Identifiers
- Catalog Number
- 92739 FDA UDI
- Primary DI / UDI-DI
- 00850019946482 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850019946EXRADINSCINTIQF 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
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
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiation condenser R-meter
Standard Imaging Exradin W1 Scintillator 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
European Union Unknown
MDR
United States Pending data
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 2b434ffd-a780-47eb-84db-62706ca85c28 34 fields · synced Jun 19, 2026
- EUDAMED c656b70b-97c0-401b-afa8-2cc4ad7eb619 61 fields · synced Jun 19, 2026