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NOMEX software

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

Ref S030008

NOMEX software (S030008) is a multi-modality therapeutic radiation phantom (EU MDD Class IIb; FDA Class I; FDA product code LHO, Instrument, Quality-Assurance, Radiologic) made by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH, registered in EUDAMED on 16 Jul 2026 (Basic UDI-DI B-+EPTWS0300080) and listed in FDA GUDID since 26 Apr 2017 (UDI-DI +EPTWS0300080), active as of 23 Oct 2026.

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

CE MDD

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+EPTWS0300080 Basic UDI-DI +EPTWS0300080UDI-DIDate16 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+EPTWS0300080 UDI-DI Date26 Apr 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-+EPTWS0300080 registered 16 Jul 2026 Active
  • FDA GUDID UDI-DI +EPTWS0300080 listed 26 Apr 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID +EPTWS0300080
  2. Registered EUDAMED B-+EPTWS0300080

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  • Withdrawn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

Trade name
Nomex
Generic name
Multi-modality therapeutic radiation phantom, anthropomorphic
Device name
NOMEX Software
Model / Ref / Catalog
S030008, NOMEX software
Primary DI / UDI-DI
+EPTWS0300080 EUDAMED
EPTWS0300080 GUDID
Basic UDI-DI
B-+EPTWS0300080
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
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
S030008
GUDID
NOMEX software
Primary DI / UDI-DIEUDAMED
+EPTWS0300080
GUDID
EPTWS0300080
Device classEUDAMED
Class IIb
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists +EPTWS0300080; FDA GUDID lists EPTWS0300080), so their flags are not compared. Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Multi-modality therapeutic radiation phantom, anthropomorphic

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

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)