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TH01 Thermocouple Sensor

by Neurotronics, LLC 10 variants

Part of a family of 10 devices: see the family page

Ref S28085Model TH01

TH01 Thermocouple Sensor (S28085) is a device classified as Class I in the EU and Class II in the US made by Neurotronics, LLC, registered in EUDAMED on 15 Aug 2023 (Basic UDI-DI 081711102THERM2W), cleared under FDA 510(k) K181709 on 16 Nov 2018 and listed in FDA GUDID since 27 Dec 2018 (UDI-DI 00817111021028), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K181709

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081711102THERM2W Basic UDI-DI 00817111021028UDI-DIDate15 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00817111021028 UDI-DI Date27 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK181709 Date16 Nov 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081711102THERM2W registered 15 Aug 2023 Active
  • FDA 510(k) K181709 decided 16 Nov 2018 Active
  • FDA GUDID UDI-DI 00817111021028 listed 27 Dec 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K181709
  2. Listed FDA GUDID 00817111021028
  3. Registered EUDAMED 081711102THERM2W

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Serenity TH01 Thermocouple Sensor, 1.5mm DIN, 2.0m
Generic name
Polysomnograph
Model / Ref / Catalog
TH01, S28085
Primary DI / UDI-DI
00817111021028
Basic UDI-DI
081711102THERM2W
Direct marketing DI
00817111021028
510(k) Number
FDA product code
OLV
EMDN code
Z12100580 Polysomnography instruments - hardware accessories
GMDN term
Polysomnograph
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1400
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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 - HARDWARE ACCESSORIES.

Other devices from Neurotronics, LLC

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)