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BP01 Body Position Sensor

by Neurotronics, LLC 3 variants

Ref S40712Model BP01

BP01 Body Position Sensor (S40712) is a device classified as Class I in the EU and Class II in the US made by Neurotronics, LLC, registered in EUDAMED on 2 Aug 2023 (Basic UDI-DI 081711102BODY2V), cleared under FDA 510(k) K173868 on 2 Jul 2018 and listed in FDA GUDID since 8 Nov 2018 (UDI-DI 00817111020847), 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) K173868

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 Number081711102BODY2V Basic UDI-DI 00817111020847UDI-DIDate2 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00817111020847 UDI-DI Date8 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173868 Date2 Jul 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081711102BODY2V registered 2 Aug 2023 Active
  • FDA 510(k) K173868 decided 2 Jul 2018 Active
  • FDA GUDID UDI-DI 00817111020847 listed 8 Nov 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173868
  2. Listed FDA GUDID 00817111020847
  3. Registered EUDAMED 081711102BODY2V

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  • Withdrawn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 BP01 Body Position Sensor, 249 Keyhole, 2.0m
Generic name
Polysomnograph
Model / Ref / Catalog
BP01, S40712
Primary DI / UDI-DI
00817111020847
Basic UDI-DI
081711102BODY2V
Direct marketing DI
00817111020847
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

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Properties

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