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Non-Adhesive Wrap

by Sentec AG

Ref 103520

Non-Adhesive Wrap (103520) is a device classified as Class I in the EU and Class II in the US made by SenTec AG, registered in EUDAMED on 10 Nov 2021 (Basic UDI-DI 764012188MARJD), cleared under FDA 510(k) K151329 on 17 Dec 2015 (3 earlier submissions) and listed in FDA GUDID since 21 Jul 2023 (UDI-DI 07640121881039), active as of 22 Oct 2026. 14 FDA recalls are linked to it.

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

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K151329

+3 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07640121881039 UDI-DI Date21 Jul 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number764012188MARJD Basic UDI-DI 07640121881039UDI-DIDate10 Nov 2021RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK151329 Date17 Dec 2015IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 764012188MARJD registered 10 Nov 2021 Active
  • FDA 510(k) K151329 decided 17 Dec 2015 Active· +3 more in the status table
  • FDA GUDID UDI-DI 07640121881039 listed 21 Jul 2023 Listed

Recalls

14 recalls · 2 ongoing · FDA

    • Ongoing Z-2592-2023 FDA Class II initiated 25 Jul 2023

    During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance.

    • Ongoing Z-1980-2023 FDA Class II initiated 2 May 2023

    The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.

    • Terminated Z-0148-2023 FDA Class II initiated 22 Aug 2022

    Weak skin adhesion.

    • Terminated Z-1134-2021 FDA Class II initiated 10 Dec 2020

    Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.

  • 5 recalls, same reason

    • Terminated Z-2154-2019 FDA Class II initiated 2 May 2019
    • Terminated Z-2155-2019 FDA Class II initiated 2 May 2019
    • Terminated Z-2153-2019 FDA Class II initiated 2 May 2019
    • Terminated Z-2152-2019 FDA Class II initiated 2 May 2019
    • Terminated Z-2156-2019 FDA Class II initiated 2 May 2019

    There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.

    • Terminated Z-0088-2017 FDA Class II initiated 15 Sep 2016

    Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A loose screw within the monitor can create uncontrolled electrical connections, including short circuits, with the risk of smolder or fire and electrical shock (patient and/or operator).

    • Terminated Z-1501-2015 FDA Class II initiated 25 Mar 2015

    SenTec is voluntarily replacing V-Sign Sensors 2 due to pre-mature deterioration of a part of the PCO2 measuring unit and thus disabling PCO2-monitoring. This means that the affected sensors reach their end-of-life earlier than normally expected requiring the sensor`s replacement. There is no increased risk for the patient or operator, because the aforementioned deterioration results in the sens

  • 2 recalls, same reason

    • Terminated Z-0434-2013 FDA Class II initiated 5 Nov 2012
    • Terminated Z-0433-2013 FDA Class II initiated 5 Nov 2012

    A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated.

    • Terminated Z-2199-2012 FDA Class II initiated 9 Jul 2012

    SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.

Timeline

20 dated events

  1. Recall initiated FDA recalls Z-2155-2019
  2. Recall initiated FDA recalls Z-2153-2019
  3. Recall initiated FDA recalls Z-2152-2019
  4. Recall initiated FDA recalls Z-2156-2019
  5. Recall initiated FDA recalls Z-1134-2021
  6. Registered EUDAMED 764012188MARJD
  7. Recall initiated FDA recalls Z-0148-2023
  8. Recall initiated FDA recalls Z-1980-2023
  9. Listed FDA GUDID 07640121881039
  10. Recall initiated FDA recalls Z-2592-2023

10 earlier events are in the sections above.

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

Generic name
Pulse Co-oximeter probe, reusable
Device name
Multi-Site Attachment Ring
Model / reference
103520
Primary DI / UDI-DI
07640121881039
Basic UDI-DI
764012188MARJD
510(k) Number
FDA product code
DPZ, LPP, LKD, KLK, DQA
EMDN code
Z1203020405, Z1203020485
GMDN term
Pulse Co-oximeter probe, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.2710, 868.2500, 868.2480, 870.2700
EU registration type
Standard device
EU market of registration
France
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
CH-MF-000008058
Authorised representative
Sentec GmbH DE-AR-000007618

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Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)