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Varex Imaging

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 158559Model AMPMC 1006

by Varex Imaging Nederland B.V.

Identity

Trade Name
Varex Imaging EUDAMEDFDA UDI
Generic Name
Multichannel radiation survey meter FDA UDI
Device Name
AMPMC series EUDAMED
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
Model / Reference
AMPMC 1006 EUDAMED
158559 EUDAMED
14315-10 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 EUDAMED
Class 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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

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