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N/A Sxg-32R

by Ecotron EUDAMEDGUDID

Active European Union and United States

Ref ECO-ER-CAT-001SModel SXG-32R

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800019200123 Basic UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800019200123 UDI-DIDate27 Oct 2016ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Expiring
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Sxg-32R EUDAMED
N/A GUDID
Generic Name
Diagnostic x-ray system generator, stationary
Device Name
High Frequency X-ray Generator
Model / Ref / Catalog
SXG-32R, ECO-ER-CAT-001S
Description
LINE POWER RATING: 230V, 50/60Hz OUTPUT RATING: 32kW(400mA@80kV, 320mA@100kV, 250mA@125kV) KVP range: 40~125kVp mA range: 10~400mA mAs Range: 0.1~400mAs
Primary DI / UDI-DI
08800019200123
Basic UDI-DI
B-08800019200123
FDA Product Code
IZO
EMDN Code
Z11039011 High voltage x-ray generators
GMDN Term
Diagnostic x-ray system generator, stationary
Device Class
Class IIb EUDAMED
Class I GUDID
Regulation Number
892.1700
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
Size
Height — 640 Millimeter
Width — 430 Millimeter
Length — 620 Millimeter
Weight — 80 Kilogram

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class I

Related devices

Category: Diagnostic x-ray system generator, stationary

Other devices from Ecotron

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Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • 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: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No