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TB5 Ref Test/Blank Sensor 10327492

by Siemens Healthcare Diagnostics Inc.

Ref 10327492Model IVDR_69_TTN_DUB-C_A_NPT_REAG_BG-RL1200/348EX

TB5 Ref Test/Blank Sensor 10327492 (673396000) is a device classified as Class A in the EU and Class II in the US made by Siemens Healthcare Diagnostics Inc., registered in EUDAMED on 21 Aug 2026 (Basic UDI-DI 0405686902184VN), cleared under FDA 510(k) K934907 on 3 Jan 1994 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00630414132013), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K934907

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686902184VN Basic UDI-DI 00630414132013UDI-DIDate21 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414132013 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK934907 Date3 Jan 1994DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0405686902184VN registered 21 Aug 2026 Active
  • FDA 510(k) K934907 decided 3 Jan 1994 Active
  • FDA GUDID UDI-DI 00630414132013 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K934907
  2. Listed FDA GUDID 00630414132013
  3. Registered EUDAMED 0405686902184VN

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
TB5 Ref Test/Blank Sensor
Generic name
Blood gas/haemoximetry analyser IVD, point-of-care
Device name
IVDR_69_TTN_DUB-C_a_npt_reag_bg-RL1200/348EX
Model / Ref / Catalog
10327492, IVDR_69_TTN_DUB-C_A_NPT_REAG_BG-RL1200/348EX, 673396000
Primary DI / UDI-DI
00630414132013
Basic UDI-DI
0405686902184VN
510(k) Number
FDA product code
CHL
EMDN code
W0201040185 Blood gas analysers - consumables
GMDN term
Blood gas/haemoximetry analyser IVD, point-of-care
Device class
Class A EUDAMED
Class II GUDID
Regulation number
862.1120
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class II

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Blood gas/haemoximetry analyser IVD, point-of-care

Cleared under the same submission (K934907)

and 6 more cleared under K934907

Similar devices in this category

Other devices filed under BLOOD GAS ANALYSERS - CONSUMABLES.

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Reagent
  • Near-patient testing
  • Professional testing
Other properties (23, all answered No)