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UNIDOS webline

by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Ref T10023

UNIDOS webline (T10023) is a radiation electrometer (EU MDD Class IIb; FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH, registered in EUDAMED on 31 Jul 2026 (Basic UDI-DI B-+EPTWT100230), cleared under FDA 510(k) K951764 on 7 Oct 1995 and listed in FDA GUDID since 26 Apr 2017 (UDI-DI +EPTWT100230), active as of 23 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K951764

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+EPTWT100230 Basic UDI-DI +EPTWT100230UDI-DIDate31 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+EPTWT100230 UDI-DI Date26 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK951764 Date7 Oct 1995DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-+EPTWT100230 registered 31 Jul 2026 Active
  • FDA 510(k) K951764 decided 7 Oct 1995 Active
  • FDA GUDID UDI-DI +EPTWT100230 listed 26 Apr 2017 Listed

Recalls

1 recall · FDA

    • Terminated Z-2439-2015 FDA Class II initiated 27 May 2015

    In some cases, especially with high dose-per-pulse-rates typical for particle (specifically proton) therapy, measuring errors can result. Individual measurement intervals can be lost that are not visible to the user when there is a high dose-per-pulse rate resulting in a too-low dose being displayed on the monitor. This could result in a radiation over-exposure.

Timeline

4 dated events

  1. Cleared FDA 510(k) K951764
  2. Recall initiated FDA recalls Z-2439-2015
  3. Listed FDA GUDID +EPTWT100230
  4. Registered EUDAMED B-+EPTWT100230

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Radiation electrometer
Model / Ref / Catalog
T10023, UNIDOS webline
Primary DI / UDI-DI
+EPTWT100230 EUDAMED
EPTWT100230 GUDID
Basic UDI-DI
B-+EPTWT100230
510(k) Number
FDA product code
IYE
EMDN code
Z119002 Dosimeters
GMDN term
Radiation electrometer
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
T10023
GUDID
UNIDOS webline
Primary DI / UDI-DIEUDAMED
+EPTWT100230
GUDID
EPTWT100230
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +EPTWT100230; FDA GUDID lists EPTWT100230), so their flags are not compared. 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: Radiation electrometer

Cleared under the same submission (K951764)

and 8 more cleared under K951764

Similar devices in this category

Other devices filed under VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS.

Other devices from PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

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Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)