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Polysmith 12.0

by Neurotronics, LLC

Ref PS12.0Model 12.0

Polysmith 12.0 (PS12.0) is a device classified as Class IIa in the EU and Class II in the US made by Neurotronics, LLC, registered in EUDAMED on 15 Aug 2023 (Basic UDI-DI B-00817111021172) and listed in FDA GUDID since 1 Apr 2020 (UDI-DI 00817111021172), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00817111021172 Basic UDI-DI 00817111021172UDI-DIDate15 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00817111021172 UDI-DI Date1 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00817111021172 registered 15 Aug 2023 Active
  • FDA GUDID UDI-DI 00817111021172 listed 1 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00817111021172
  2. Registered EUDAMED B-00817111021172

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  • Withdrawn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
Polysmith Version 12.0
Generic name
Sleep disorder interpretive software, professional-only
Device name
Polysmith 12.0
Model / reference
12.0, PS12.0
Primary DI / UDI-DI
00817111021172
Basic UDI-DI
B-00817111021172
FDA product code
OLZ, OLV, DQA, MNR, GWL, MLO
EMDN code
Z12100592 Polysomnography instruments - medical device software
GMDN term
Sleep disorder interpretive software, professional-only
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1400, 870.2700, 868.2375, 882.1835, 870.2800
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000030839
Authorised representative
NIHON KOHDEN EUROPE GmbH DE-AR-000010740

Similar devices in this category

Other devices filed under POLYSOMNOGRAPHY INSTRUMENTS.

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Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)