SenTec AG
Active in EUDAMEDSwitzerlandfrom SRN EUDAMED FDA SRN CH-MF-000008529 FEI 3004149774
SenTec AG is a medical device manufacturer based in Switzerland, with 98 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (EU Class I and IIa; FDA Class II) and 14 FDA recalls as of 12 Nov 2026.
- Devices
- 98
- Registrations
- EUDAMEDFDA
- FDA recalls
- 142 ongoing
Registry facts
- Registries
- FDA GUDID 79
- EUDAMED 53
- FDA 510(k) 5
- Device classes
- EU Class I 51
- FDA Class II 45
- EU Class IIa 2
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Sentec GmbH authorised representative
- Identifiers
- EUDAMED SRN CH-MF-000008529
- FDA FEI 3004149774
- DUNS 480797856
At a glance
EU certificates
1 of 3 in force. 1 certificate has expired.
Market reach
- European Union
- EUDAMED actor, 3 certificates
- United States
- FDA establishment, FDA recalls
- Authorised rep.
- Sentec GmbHDE
Catalogue
Search and filter all 98 devicesShowing 1-50 of 98
Company details
- EUDAMED SRN
- CH-MF-000008529
- FDA FEI number
- 3004149774
- DUNS number
- 480797856
- EU VAT number
- CHE-105.218.340
- EUDAMED status
- Active
- EUDAMED registered name
- Sentec AG
- Registered address
- 14, Kantonsstrasse, 7302, Landquart, Switzerland
- Website
- www.sentec.com
- info-eit@sentec.com
- PRRC contact
- Petra Netter
1 more person
- Caroline Möller
EUDAMED certificates
3 certificates1 valid, 1 expired, 1 withdrawn or suspendedMDR 3next expiry 8 Aug 2031
TÜV SÜD Product Service GmbH 0123 2 certificates
- G15 005260 0005 Active
Quality management system EU MDR
- Issued
- 5 Aug 2026
- Expires
- 8 Aug 2031
- Valid from
- 9 Aug 2026
- Reason
- Other
- G10 005260 0004 Expired
Quality management system EU MDR
- Issued
- 4 Sep 2024
- Expires
- 8 Aug 2026
mdc medical device certification GmbH 0483 1 certificate
- D1419900013 Withdrawn
Quality management system EU MDR
- Issued
- 20 Mar 2026
- Expires
- 16 Dec 2026
- Reason
- Other
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 5
- 2020 1
- 2021 0
- 2022 1
- 2023 2
- 2024 0
- 2025 0
- 2026 0
2023
- 25 Jul 2023 Z-2592-2023 Class II Ongoing 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.
- 2 May 2023 Z-1980-2023 Class II Ongoing 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.
2022
- 22 Aug 2022 Z-0148-2023 Class II Terminated Weak skin adhesion.
2020
- 10 Dec 2020 Z-1134-2021 Class II Terminated Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
2019
- 2 May 2019 Z-2152-2019 Class II Terminated 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.
Full distribution text
- 2 May 2019 Z-2153-2019 Class II Terminated 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.
Full distribution text
- 2 May 2019 Z-2154-2019 Class II Terminated 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.
Full distribution text
- 2 May 2019 Z-2155-2019 Class II Terminated 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.
Full distribution text
- 2 May 2019 Z-2156-2019 Class II Terminated 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.
Full distribution text
- 2 May 2019 Z-2152-2019 Class II Terminated 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.
2016
- 15 Sep 2016 Z-0088-2017 Class II Terminated 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).
Full distribution text
- 15 Sep 2016 Z-0088-2017 Class II Terminated 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).
Show all 14 recalls
2015
- 25 Mar 2015 Z-1501-2015 Class II Terminated 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
2012
- 5 Nov 2012 Z-0433-2013 Class II Terminated 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.
- 5 Nov 2012 Z-0434-2013 Class II Terminated 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.
- 9 Jul 2012 Z-2199-2012 Class II Terminated SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.
Full distribution text
FDA establishments
- Sentec, Inc. Lincoln, RI · US FEI 3012409105
Frequently asked questions
How many devices does SenTec AG have in the registry?
The registry currently lists 98 devices for SenTec AG. Devices recorded under merged duplicate company entries are counted once.
Which registries list SenTec AG's devices?
Among its 50 most recently registered devices, SenTec AG has devices listed in EUDAMED (19 devices) and FDA GUDID (44 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do SenTec AG's devices fall under?
Among its 50 most recently registered devices, the classes recorded for SenTec AG's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for SenTec AG?
FDA recall records list 14 recalls initiated by SenTec AG, the most recent initiated on 25 Jul 2023. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for SenTec AG?
EUDAMED lists 3 certificates for SenTec AG (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 5 Aug 2026.
What are the newest devices from SenTec AG in the registry?
The most recently registered devices listed for SenTec AG include LuMon™ Belt 92, LuMon™ Belt 30, LuMon™ Belt 136 and LuMon™ Belt 70.