Varex Imaging
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Varex Imaging EUDAMEDFDA UDI
- Generic Name
- Solid-state-semiconductor radiation measuring probe FDA UDI
- Device Name
- SolidStateMC series MDD EUDAMEDThis is a set consisting out of an AEC sensor from the SolidStateMC series and an amplifier from AmpMC-series. FDA UDI
- Model / Reference
- SolidStateMC set 501, 1001 EUDAMED163813 EUDAMED18893-10 FDA UDI
- Description
- This is a set consisting out of an AEC sensor from the SolidStateMC series and an amplifier from AmpMC-series. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718755001174 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08718755001174 EUDAMED
- FDA Product Code
- IZO FDA UDI
- EMDN Code
- Z11030599 RADIOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Solid-state-semiconductor radiation measuring probe FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1700 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Solid-state-semiconductor radiation measuring probeMultichannel radiation survey meter
Varex Imaging by Varex Imaging Nederland B.V. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Multichannel radiation survey meter.
- Varex Imaging — Varex Imaging Nederland B.V. · Class I
- Varex Imaging — Varex Imaging Nederland B.V. · Class I
- Varex Imaging — Varex Imaging Nederland B.V. · Class I
- Varex Imaging — Varex Imaging Nederland B.V. · Class I
- Varex Imaging — Varex Imaging Nederland B.V. · Class I
- Varex Imaging — Varex Imaging Nederland B.V. · Class I
- Varex Imaging — Varex Imaging Nederland B.V. · Class I
- Varex Imaging — Varex Imaging Nederland B.V. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Varex Imaging Nederland B.V.
Sources (2)
- FDA UDI d32f2127-28e1-4c04-ba3a-d48d37d7c486 33 fields · synced Sep 30, 2026
- EUDAMED 00447fab-8862-4d5b-bc4d-79f5f31c2366 61 fields · synced Jun 18, 2026