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Standard Imaging Exradin Magna 600
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 92600
Identity
- Trade Name
- Exradin Magna 1cc EUDAMEDStandard Imaging Exradin Magna 600 FDA UDI
- Generic Name
- Radiation condenser R-meter FDA UDI
- Device Name
- Exradin Ion Chamber EUDAMEDStandard Imaging Exradin Magna 600 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental). FDA UDI
- Model / Reference
- 92600 EUDAMEDFDA UDI
- Description
- Standard Imaging Exradin Magna 600 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental). FDA UDI
Identifiers
- Catalog Number
- 92600 FDA UDI
- Primary DI / UDI-DI
- 00850019946130 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 Magna 600 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 54f1efc6-afec-411d-ae25-a83243f736e7 34 fields · synced Jul 14, 2026
- EUDAMED aa5f305d-3822-475f-9744-30f585659ba8 61 fields · synced Jul 14, 2026