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NA IsoCheck software

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

Ref S070019

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

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+EPTWS0700190 Basic UDI-DI +EPTWS0700190UDI-DIDate16 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+EPTWS0700190 UDI-DI Date26 Apr 2017ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic Name
Multi-modality therapeutic radiation phantom, anthropomorphic
Device Name
IsoCheck
Model / Ref / Catalog
S070019, IsoCheck software
Primary DI / UDI-DI
+EPTWS0700190 EUDAMED
EPTWS0700190 GUDID
Basic UDI-DI
B-+EPTWS0700190
FDA Product Code
LHO
EMDN Code
Z119002 Dosimeters
GMDN Term
Multi-modality therapeutic radiation phantom, anthropomorphic
Device Class
Class IIb EUDAMED
Class I GUDID
Regulation Number
892.1940
Special Device Type
-1192
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
S070019
GUDID
IsoCheck software
Primary DI / UDI-DIEUDAMED
+EPTWS0700190
GUDID
EPTWS0700190
Device ClassEUDAMED
Class IIb
GUDID
Class I

Related devices

Category: Multi-modality therapeutic radiation phantom, anthropomorphic

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Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

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