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Advanced Markus

by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH 2 variants

Ref TM34045

Advanced Markus (TM34045) is an ionization chamber radiation measuring probe (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 14 Jul 2026 (Basic UDI-DI B-+EPTWTM340450), cleared under FDA 510(k) K961208 on 17 Jun 1996 and listed in FDA GUDID since 27 Apr 2017 (UDI-DI +EPTWTM340450), active as of 23 Oct 2026.

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 found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K961208

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-+EPTWTM340450 Basic UDI-DI +EPTWTM340450UDI-DIDate14 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+EPTWTM340450 UDI-DI Date27 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK961208 Date17 Jun 1996DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-+EPTWTM340450 registered 14 Jul 2026 Active
  • FDA 510(k) K961208 decided 17 Jun 1996 Active
  • FDA GUDID UDI-DI +EPTWTM340450 listed 27 Apr 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K961208
  2. Listed FDA GUDID +EPTWTM340450
  3. Registered EUDAMED B-+EPTWTM340450

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  • Withdrawn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
Ionization chamber radiation measuring probe
Device name
Advanced Markus chamber 0.02 cm³
Model / Ref / Catalog
TM34045, Advanced Markus electron chamber 0.02 cm³
Primary DI / UDI-DI
+EPTWTM340450 EUDAMED
EPTWTM340450 GUDID
Basic UDI-DI
B-+EPTWTM340450
510(k) Number
FDA product code
IYE
EMDN code
Z119002 Dosimeters
GMDN term
Ionization chamber radiation measuring probe
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
TM34045
GUDID
Advanced Markus electron chamber 0.02 cm³
Primary DI / UDI-DIEUDAMED
+EPTWTM340450
GUDID
EPTWTM340450
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +EPTWTM340450; FDA GUDID lists EPTWTM340450), 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: Ionization chamber radiation measuring probe

Cleared under the same submission (K961208)

and 8 more cleared under K961208

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

See all devices from PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)