Contact Gel

Ref GEL-SD

Contact Gel (GEL-SD) is a device classified as Class I in the EU and Class II in the US made by SenTec AG, registered in EUDAMED on 17 Nov 2021 (Basic UDI-DI 764012188GELHF), cleared under FDA 510(k) K151329 on 17 Dec 2015 (3 earlier submissions) and listed in FDA GUDID since 5 Mar 2019 (UDI-DI 17640121880862), 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, self-declared

Class I: no certifier involved

510(k) K151329

+3 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number764012188GELHF Basic UDI-DI 17640121880862UDI-DI	Date17 Nov 2021Registered	StatusActive
United States	GUDID listing GUDID	Number17640121880862 UDI-DI	Date5 Mar 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) GUDID from GUDID	NumberK151329	Date17 Dec 2015Issued	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK101690	Date3 Dec 2010Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK071672	Date12 Sep 2007Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK041548	Date9 Aug 2004Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 764012188GELHF — open Devices and search for it
AccessGUDID record UDI-DI 17640121880862
FDA 510(k) database 510(k) number K151329
FDA 510(k) database 510(k) number K101690
FDA 510(k) database 510(k) number K071672
FDA 510(k) database 510(k) number K041548

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 764012188GELHF registered 17 Nov 2021 Active
FDA 510(k) K151329 decided 17 Dec 2015 Active· +3 more in the status table
FDA GUDID UDI-DI 17640121880862 listed 5 Mar 2019 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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

2 May 2019 Recall initiated FDA recalls Z-2154-2019
2 May 2019 Recall initiated FDA recalls Z-2155-2019
2 May 2019 Recall initiated FDA recalls Z-2153-2019
2 May 2019 Recall initiated FDA recalls Z-2152-2019
2 May 2019 Recall initiated FDA recalls Z-2156-2019
10 Dec 2020 Recall initiated FDA recalls Z-1134-2021
17 Nov 2021 Registered EUDAMED 764012188GELHF
22 Aug 2022 Recall initiated FDA recalls Z-0148-2023
2 May 2023 Recall initiated FDA recalls Z-1980-2023
25 Jul 2023 Recall initiated FDA recalls Z-2592-2023

10 earlier events are in the sections above.

Coverage

2 jurisdictions

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
Model / reference: GEL-SD

Primary DI / UDI-DI: 17640121880862
Basic UDI-DI: 764012188GELHF
510(k) Number: K041548
K071672
K101690
K151329
FDA product code: LPP, LKD, KLK, DQA, DPZ
EMDN code: Z1203020405 Transcutaneous po2/pco2 monitors
GMDN term: Pulse Co-oximeter probe, reusable

Device class: Class I EUDAMED
Class II GUDID
Regulation number: 868.2500, 868.2480, 870.2700, 870.2710
EU registration type: Standard device
EU market of registration: Germany
GUDID distribution status: In Commercial Distribution

Size: Weight — 0.3 Gram

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED 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

Single use
Prescription use
Lot / batch number
Expiration date

Other properties (21, all answered No)