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Dimension® Flex® reagent cartridge PROC 10444937

by Siemens Healthcare Diagnostics Inc.

Ref 10444937Model DX_LS_LEGACY_00842768005282

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00842768005282 Basic UDI-DI 00842768005282UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768005282 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Dimension Procainamide Flex reagent cartridge EUDAMED
Dimension® Flex® reagent cartridge PROC GUDID
Generic Name
Procainamide therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Device Name
DX_LS_LEGACY_00842768005282
Model / Ref / Catalog
10444937, DX_LS_LEGACY_00842768005282, DF110
Primary DI / UDI-DI
00842768005282
Basic UDI-DI
B-00842768005282
510(k) Number
FDA Product Code
LAR
EMDN Code
W0102080107 Procainamide
GMDN Term
Procainamide therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
862.3320
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IVD General
GUDID
Class II

Related devices

Category: Procainamide therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Cleared under the same submission (K032573)

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No