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Isansys

by Isansys Lifecare Ltd 9 variants

Part of a family of 11 devices: see the family page

Ref Lifetemp SmallModel PSE_2

Isansys (Lifetemp Small), a medical device (EU MDR Class IIa; FDA Class II; FDA product code DRG, Transmitters And Receivers, Physiological Signal, Radiofrequency; EMDN category measurement devices) made by Isansys Lifecare, Ltd., was registered in EUDAMED on 30 Jun 2022 (Basic UDI-DI 506048868PSE2EG), cleared under FDA 510(k) K172329 on 23 Apr 2018 and listed in FDA GUDID on 26 Apr 2024 (UDI-DI 05060488680014); the registry lists it as withdrawn (EUDAMED) as of 25 Oct 2026.

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 Withdrawn in European Union.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

CE MDR, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172329

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05060488680014 UDI-DI Date26 Apr 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number506048868PSE2EG Basic UDI-DI 05060488680014UDI-DIDate30 Jun 2022RegisteredStatusWithdrawn No longer placed on the EU market
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK172329 Date23 Apr 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506048868PSE2EG registered 30 Jun 2022 Withdrawn
  • FDA 510(k) K172329 decided 23 Apr 2018 Active
  • FDA GUDID UDI-DI 05060488680014 listed 26 Apr 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K172329
  2. Registered EUDAMED 506048868PSE2EG
  3. Listed FDA GUDID 05060488680014

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDR Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Physiological measuring device wireless data capture/transfer unit
Device name
Patient Status Engine
Model / Ref / Catalog
PSE_2 EUDAMED
Lifetemp Small EUDAMED
Lifetemp Sensor - Small GUDID
Primary DI / UDI-DI
05060488680014
Basic UDI-DI
506048868PSE2EG
Direct marketing DI
05060488680014
510(k) Number
FDA product code
DRG
EMDN code
V0399 Measurement devices - other
GMDN term
Physiological measuring device wireless data capture/transfer unit
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2910
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
PSE_2
Lifetemp Small
GUDID
Lifetemp Sensor - Small
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
GB-MF-000022154
Authorised representative
Isansys Lifecare Europe GmbH DE-AR-000009967

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Properties

  • Single use
  • Measuring function
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)