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Isansys

by Isansys Lifecare Ltd 9 variants

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

Ref Gateway SM-X205 GSM, Lifetouch Neonate, Lifetouch Neonate Snap, Lifetemp Sensor - V2 - Medium, Lifetouch Sensor - Large, Lifetouch SmallModel PSE_2

Isansys (Gateway SM-X205 GSM) is 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., 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 since 25 Apr 2024 (UDI-DI 05060488680311), 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) K172329

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05060488680311 UDI-DI Date25 Apr 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number506048868PSE2EG Basic UDI-DI Date30 Jun 2022RegisteredStatusActive
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 Active
  • FDA 510(k) K172329 decided 23 Apr 2018 Active
  • FDA GUDID UDI-DI 05060488680311 listed 25 Apr 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K172329
  2. Registered EUDAMED 506048868PSE2EG
  3. Listed FDA GUDID 05060488680311

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  • Withdrawn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
Isansys EUDAMEDGUDID
Patient Gateway GUDID
Generic name
Physiological measuring device wireless data capture/transfer unit
Device name
Patient Status Engine
Model / Ref / Catalog
PSE_2, Gateway SM-X205 GSM, Lifetouch Neonate, Lifetouch Neonate Snap, Lifetouch Sensor - Large, Lifetemp Sensor - V2 - Medium, Lifetouch Small, SM-X205 - 10.5 Screen - GSM, Lifetouch Sensor - Small
Description
Continuous Cardiac Sensor
Continuous Clinical Thermometer
SM-X205 - 10.5 Screen - GSM Data entry & local display point tablet computer, 10.5 Screen
Primary DI / UDI-DI
05060488680311, 05060488680076, 05060488680083, 05060488680113, 05060488680281, 05060488680090
Basic UDI-DI
506048868PSE2EG
Direct marketing DI
05060488680311
05060488680076
05060488680083
05060488680281
05060488680113
05060488680090
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 Unsafe

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
GB-MF-000022154
Authorised representative
Isansys Lifecare Europe GmbH DE-AR-000009967

Similar devices in this category

Other devices filed under MEASUREMENT DEVICES - OTHER.

Other devices from Isansys Lifecare, Ltd.

See all devices from Isansys Lifecare, Ltd. →

Properties

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