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Sopix2

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref S_802_0005Model S_802_0001.

by Sopro

Identity

Trade Name
SOPIX2 EUDAMED
ACTEON FDA UDI
Generic Name
Dental digital imaging sensor, intraoral FDA UDI
Device Name
SOPIX2 EUDAMED
"The SOPIX series digital X-ray imaging systems are intended to be used by a dental practitioner. The sensor (located in the patient’s mouth just like a silver fi lm) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen. All the images captured with the SOPIX series system can be recalled onto the screen with the Sopro Imaging software provided with the system. This software manages the display, processing and storage of images taken with the SOPIX series system. A.C.E™ (Automatic Control Exposure) technology, patented by SOPRO, provides the system with outstanding features. In real time it analyses the quantity of energy received by the sensor, which fi xes the image acquisition once it has received the energy needed to produce a good-quality image. As a result, every image is protected against overexposure." FDA UDI
Model / Reference
S_802_0001. EUDAMED
S_802_0005 EUDAMED
CAPT SOPIX² T2 USB2 CONDO FDA UDI
Description
"The SOPIX series digital X-ray imaging systems are intended to be used by a dental practitioner. The sensor (located in the patient’s mouth just like a silver fi lm) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen. All the images captured with the SOPIX series system can be recalled onto the screen with the Sopro Imaging software provided with the system. This software manages the display, processing and storage of images taken with the SOPIX series system. A.C.E™ (Automatic Control Exposure) technology, patented by SOPRO, provides the system with outstanding features. In real time it analyses the quantity of energy received by the sensor, which fi xes the image acquisition once it has received the energy needed to produce a good-quality image. As a result, every image is protected against overexposure." FDA UDI

Identifiers

Catalog Number
S_802_0005 FDA UDI
Primary DI / UDI-DI
03760278264074 EUDAMED
M430S80200051 FDA UDI
Basic UDI-DI
801337602782D0009D7 EUDAMED
Direct Marketing DI
03760278267105 EUDAMED
510(k) Number
K092329 FDA UDI
FDA Product Code
MUH FDA UDI
EMDN Code
Z1103040102 EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY EUDAMED
GMDN Term
Dental digital imaging sensor, intraoral FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
872.1800 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

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sopix2 by Sopro — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sopro
EUDAMED SRN
FR-MF-000000833

Sources (2)

  • EUDAMED a3ae7927-85d2-4a5e-ae32-ebce64afa3ed 61 fields · synced May 31, 2026
  • FDA UDI cbb1f28a-2b1f-4c27-bc84-a8b1ce3319c7 36 fields · synced May 30, 2026