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Standard Imaging Exradin A3 Ion Chamber
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 92717
Identity
- Trade Name
- Exradin A3 EUDAMEDStandard Imaging Exradin A3 Ion Chamber FDA UDI
- Generic Name
- Radiation condenser R-meter FDA UDI
- Device Name
- Exradin Ion Chamber EUDAMEDStandard Imaging Exradin A3 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental). FDA UDI
- Model / Reference
- 92717 EUDAMEDFDA UDI
- Description
- Standard Imaging Exradin A3 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental). FDA UDI
Identifiers
- Catalog Number
- 92717 FDA UDI
- Primary DI / UDI-DI
- 00850019946253 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850019946EXRADINICL5 EUDAMED
- FDA Product Code
- LHO FDA UDI
- EMDN Code
- Z11019082 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES 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 A3 Ion Chamber 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 88fb8b42-27d0-47f1-9013-547c9b146bb0 34 fields · synced Aug 4, 2026
- EUDAMED 87bd3304-7e97-4a02-a17a-573911bf1a58 61 fields · synced Aug 4, 2026