Skip to content

microDiamond

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

Ref TW60019

microDiamond (TW60019) 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 6 Aug 2026 (Basic UDI-DI B-+EPTWTW600190), cleared under FDA 510(k) K010916 on 20 Jun 2001 and listed in FDA GUDID since 27 Apr 2017 (UDI-DI +EPTWTW600190), 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) K010916

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-+EPTWTW600190 Basic UDI-DI +EPTWTW600190UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+EPTWTW600190 UDI-DI Date27 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK010916 Date20 Jun 2001DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-+EPTWTW600190 registered 6 Aug 2026 Active
  • FDA 510(k) K010916 decided 20 Jun 2001 Active
  • FDA GUDID UDI-DI +EPTWTW600190 listed 27 Apr 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K010916
  2. Listed FDA GUDID +EPTWTW600190
  3. Registered EUDAMED B-+EPTWTW600190

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  • Withdrawn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
Model / Ref / Catalog
TW60019, microDiamond
Primary DI / UDI-DI
+EPTWTW600190 EUDAMED
EPTWTW600190 GUDID
Basic UDI-DI
B-+EPTWTW600190
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
TW60019
GUDID
microDiamond
Primary DI / UDI-DIEUDAMED
+EPTWTW600190
GUDID
EPTWTW600190
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +EPTWTW600190; FDA GUDID lists EPTWTW600190), 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 (K010916)

and 8 more cleared under K010916

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)