Identity
- Trade Name
- Varex Imaging EUDAMEDFDA UDI
- Generic Name
- Multichannel radiation survey meter FDA UDI
- Device Name
- AMPMC series EUDAMEDThe AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series. FDA UDI
- Model / Reference
- AMPMC 1006 EUDAMED158559 EUDAMED14315-10 FDA UDI
- Description
- The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718755000948 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08718755000948 EUDAMED
- FDA Product Code
- IZO FDA UDI
- EMDN Code
- Z11030599 RADIOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Multichannel radiation survey meter FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1700 FDA UDI
- Market of Registration
- Spain 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
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: Multichannel 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
European Union Unknown
MDD
United States Pending data
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 ac220265-4113-4c1c-9f8c-d4acf2d9032f 33 fields · synced Jun 19, 2026
- EUDAMED 4828f65c-82be-4acf-972f-04a1f83a3780 61 fields · synced Jun 14, 2026