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Hemastix

by Siemens Healthcare Diagnostics Inc.

Ref 10317353Model IVDR_69_TTN_DUB-C_C_SELF_REAG_MICR_De-Centralized Urin Stat

Hemastix (10317353) is a Class C device made by Siemens Healthcare Diagnostics Inc., registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI 0405686901973WJ) with CE/IVDR certificate IX 1290554-10 valid until 25 Jun 2028, active as of 24 Oct 2026.

Active European Union

CE IVDR

Valid until

25 Jun 2028

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV Rheinland LGA Products GmbH

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901973WJ Basic UDI-DI 00630414984964UDI-DIDate24 Aug 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Timeline

3 dated events

  1. Certificate issued EUDAMED IX 1290554-10
  2. Registered EUDAMED 0405686901973WJ
  3. Certificate expires EUDAMED IX 1290554-10

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
IVDR_69_TTN_DUB-C_C_SELF_REAG_MICR_De-Centralized Urin Stat
Model / reference
IVDR_69_TTN_DUB-C_C_SELF_REAG_MICR_De-Centralized Urin Stat, 10317353
Primary DI / UDI-DI
00630414984964
Basic UDI-DI
0405686901973WJ
Unit of use DI
00630414306520
EMDN code
W0101060205 Urine multi-constituent test strips (automated)
Device class
Class C
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000016560
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763

Similar devices in this category

Other devices filed under URINE TESTING (CC) - RT & POC.

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Properties

  • Contains substances of microbial origin
  • Reagent
  • Self-testing
  • Near-patient testing
Other properties (9, all answered No)