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Ready Sensor™ GOLD Reference Sensor Inner Element 10329947

by Siemens Healthcare Diagnostics Inc.

Part of a family of 21 devices: see the family page

Ref 10329947Model IVDR_69_TTN_DUB-C_C_NPT_REAG_BG-348EX

Ready Sensor™ GOLD Reference Sensor Inner Element 10329947 (478509) is a device classified as Class C in the EU and Class II in the US made by Siemens Healthcare Diagnostics Inc., registered in EUDAMED on 26 May 2026 (Basic UDI-DI 0405686901946WF) with CE/IVDR certificate IX 1290554-11 valid until 8 Dec 2029, cleared under FDA 510(k) K962021 on 24 Jun 1996 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00630414115030), active as of 24 Oct 2026.

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

CE IVDR 510(k)

Valid until

8 Dec 2029

CE IVDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier TÜV Rheinland LGA Products GmbH

510(k) K962021

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686901946WF Basic UDI-DI 00630414115030UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414115030 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK962021 Date24 Jun 1996DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0405686901946WF registered 26 May 2026 Active· +1 more in the status table
  • FDA 510(k) K962021 decided 24 Jun 1996 Active
  • FDA GUDID UDI-DI 00630414115030 listed 24 Sep 2016 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Timeline

5 dated events

  1. Cleared FDA 510(k) K962021
  2. Listed FDA GUDID 00630414115030
  3. Certificate issued EUDAMED IX 1290554-11
  4. Registered EUDAMED 0405686901946WF
  5. Certificate expires EUDAMED IX 1290554-11

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  • Withdrawn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
Ready Sensor - Reference Inner EUDAMED
Ready Sensor™ GOLD Reference Sensor Inner Element GUDID
Generic name
Ion selective electrode (ISE) reference solution IVD, reagent
Device name
IVDR_69_TTN_DUB-C_c_npt_reag_bg-348EX
Model / Ref / Catalog
10329947, IVDR_69_TTN_DUB-C_C_NPT_REAG_BG-348EX, 478509
Primary DI / UDI-DI
00630414115030
Basic UDI-DI
0405686901946WF
510(k) Number
FDA product code
JGS, CEM, CHL, CGZ, JFP
EMDN code
W0101060605 Bg &/or ise &/or metabolites - electrodes (bg)
GMDN term
Ion selective electrode (ISE) reference solution IVD, reagent
Device class
Class C EUDAMED
Class II GUDID
Regulation number
862.1665, 862.1600, 862.1120, 862.1170, 862.1145
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class C
GUDID
Class II

Device class is stated on each registry's own scale: Class C 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: Ion selective electrode (ISE) reference solution IVD, reagent

Cleared under the same submission (K962021)

and 1 more cleared under K962021

Similar devices in this category

Other devices filed under ELECTRODES OR CASSETTES FOR BLOOD GAS ANALYSIS INCL. ELECTROLYTES / METABOLITES - POC.

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Contains animal tissues or cells
  • Reagent
  • Near-patient testing
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)