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Extron 5

by Drtech Corp.

Ref EXTRON 5

Extron 5 is a device classified as Class IIb in the EU and Class II in the US made by Drtech Corp., registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 88000184SCXXXXXXXX4P) and listed in FDA GUDID since 24 Aug 2023 (UDI-DI 08800018420805), active as of 7 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Oct 2026.

Regulatory status

as of registry sync 7 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000184SCXXXXXXXX4P Basic UDI-DI 08800018420805UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800018420805 UDI-DI Date24 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000184SCXXXXXXXX4P registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 08800018420805 listed 24 Aug 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800018420805
  2. Registered EUDAMED 88000184SCXXXXXXXX4P

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Mobile general-purpose fluoroscopic x-ray system, digital
Device name
Mobile Fluoroscopic X-ray System
Model / reference
EXTRON 5
Primary DI / UDI-DI
08800018420805
Basic UDI-DI
88000184SCXXXXXXXX4P
Direct marketing DI
08800018420805
FDA product code
OWB, OXO, JAA
EMDN code
Z11039017 Mobile radioscopic units
GMDN term
Mobile general-purpose fluoroscopic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1650
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Mobile general-purpose fluoroscopic x-ray system, digital

Other devices from Drtech Corp.

See all devices from Drtech Corp. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)