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Standard Imaging Exradin A12MR Ion Chamber
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 92905Ref 92903Ref 92904
Identity
- Trade Name
- Exradin A12SMR EUDAMEDExradin A19MR EUDAMEDExradin A12MR EUDAMEDStandard Imaging Exradin A12MR Ion Chamber FDA UDIStandard Imaging Exradin A19MR Ion Chamber FDA UDIStandard Imaging Exradin A12SMR Ion Chamber FDA UDI
- Generic Name
- Radiation condenser R-meter FDA UDI
- Device Name
- Exradin Ion Chamber EUDAMEDStandard Imaging Exradin A12MR is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental). FDA UDIStandard Imaging Exradin A19MR is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental). FDA UDIStandard Imaging Exradin A12SMR is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental). FDA UDI
- Model / Reference
- 92904 EUDAMEDFDA UDI92903 EUDAMEDFDA UDI92905 EUDAMEDFDA UDI
- Description
- Standard Imaging Exradin A12MR is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental). FDA UDIStandard Imaging Exradin A19MR is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental). FDA UDIStandard Imaging Exradin A12SMR is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental). FDA UDI
Identifiers
- Catalog Number
- 92904 FDA UDI92903 FDA UDI92905 FDA UDI
- Primary DI / UDI-DI
- 00850019946444 EUDAMEDFDA UDI00850019946437 EUDAMEDFDA UDI00850019946451 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
MR Conditional FDA UDI
Category: Radiation condenser R-meter
Standard Imaging Exradin A12MR 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 (6)
- FDA UDI b2ceb6fd-c25d-4ee7-92be-0effa9762556 34 fields · synced Aug 1, 2026
- FDA UDI d86c3df7-bb54-4c5a-a2aa-0eaef6f2ff31 34 fields · synced May 30, 2026
- FDA UDI 0fce8eb8-6086-406e-9a75-eba3c2aaf916 34 fields · synced May 30, 2026
- EUDAMED 4b0a5178-f09e-411d-9174-2638cc63d1eb 61 fields · synced Jul 19, 2026
- EUDAMED 93884a94-70c4-4901-b08a-c4c90e0d98c9 61 fields · synced Jul 20, 2026
- EUDAMED a227df11-fcce-4c65-a02d-772cfaaa7c68 61 fields · synced Jul 28, 2026