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Standard Imaging MAX 4000 Plus Electrometer
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 90020
Identity
- Trade Name
- Max 4000 Plus Electrometer EUDAMEDStandard Imaging MAX 4000 Plus Electrometer FDA UDI
- Generic Name
- Radiation electrometer FDA UDI
- Device Name
- Electrometer EUDAMEDStandard Imaging MAX 4000 Plus Electrometer is a portable electrometer designed to be connected to a radiation detector, (ionization chamber, well chamber, or diode detector), and measure the electrical current produced by the detector during irradiation. FDA UDI
- Model / Reference
- 90020 EUDAMEDFDA UDI
- Description
- Standard Imaging MAX 4000 Plus Electrometer is a portable electrometer designed to be connected to a radiation detector, (ionization chamber, well chamber, or diode detector), and measure the electrical current produced by the detector during irradiation. FDA UDI
Identifiers
- Catalog Number
- 90020 FDA UDI
- Primary DI / UDI-DI
- 00850019946086 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850019946ELECTROMETER7L EUDAMED
- FDA Product Code
- LHO FDA UDI
- EMDN Code
- Z11019082 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiation electrometer 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 electrometer
Standard Imaging MAX 4000 Plus Electrometer by Standard Imaging, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Radiation electrometer.
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- Built-up cap for ION Chambers — IBA Dosimetry GmbH · Class II
- NACP Parallel plate ionization chamber — IBA Dosimetry GmbH · Class II
- Built-up cap for ION Chambers — IBA Dosimetry GmbH · Class II
- Stealth Chamber — IBA Dosimetry GmbH · Class II
- StingRay — IBA Dosimetry GmbH · Class II
- UNIDOS webline — PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH · Class II
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 72dec08c-fead-477d-b004-35baf642bc58 34 fields · synced Jul 23, 2026
- EUDAMED 36ee6ddd-e318-46d1-badb-bae77899c1dd 61 fields · synced Jul 23, 2026