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Sensor Adapter Cable (Regular)

by Sentec AG

Part of a family of 6 devices: see the family page

Ref 103420

Sensor Adapter Cable (Regular) (103420) is a device classified as Class I in the EU and Class II in the US made by SenTec AG, cleared under FDA 510(k) K232516 on 17 May 2024, registered in EUDAMED on 9 Nov 2021 (Basic UDI-DI 764012188ACRM) and listed in FDA GUDID since 5 Jul 2024 (UDI-DI 07640121881008), 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) K232516

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 Number07640121881008 UDI-DI Date5 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK232516 Date17 May 2024DecidedStatusActive
European UnionCE/MDR EUDAMED Number764012188ACRM Basic UDI-DI 07640121881008UDI-DIDate9 Nov 2021RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K232516 decided 17 May 2024 Active
  • EUDAMED Basic UDI-DI 764012188ACRM registered 9 Nov 2021 Active
  • FDA GUDID UDI-DI 07640121881008 listed 5 Jul 2024 Listed

Timeline

3 dated events

  1. Registered EUDAMED 764012188ACRM
  2. Cleared FDA 510(k) K232516
  3. Listed FDA GUDID 07640121881008

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  • Withdrawn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
Sensor Adapter Cable (Regular) EUDAMED
103420 Sensor Adapter Cable (Regular) GUDID
Generic name
Transcutaneous blood gas monitoring system
Device name
Extension Cable
Model / reference
103420
Primary DI / UDI-DI
07640121881008
Basic UDI-DI
764012188ACRM
510(k) Number
FDA product code
DPZ, DQA, KLK, LKD, LPP
EMDN code
Z1203020405 Transcutaneous po2/pco2 monitors
GMDN term
Transcutaneous blood gas monitoring system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.2710, 870.2700, 868.2500, 868.2480
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 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

Similar devices in this category

Other devices filed under GASEOUS EXCHANGE MONITORING INSTRUMENTS.

Other devices from SenTec AG

See all devices from SenTec AG →

Properties

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