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Dimension® PCHE Verifier 10444987

by Siemens Healthcare Diagnostics Inc.

Ref 10444987Model DX LS_LEGACY_00842768005077

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-00842768005077 Basic UDI-DI 00842768005077UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768005077 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  • Withdrawn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 Pseudocholinesterase Verifier EUDAMED
Dimension® PCHE Verifier GUDID
Generic Name
Pseudocholinesterase IVD, control
Device Name
Dx LS_LEGACY_00842768005077
Model / Ref / Catalog
10444987, DX LS_LEGACY_00842768005077, DC28
Primary DI / UDI-DI
00842768005077
Basic UDI-DI
B-00842768005077
510(k) Number
FDA Product Code
LAS
EMDN Code
W0101050302 Calibrators single component (cc)
GMDN Term
Pseudocholinesterase IVD, control
Device Class
Class IVD General EUDAMED
Class I GUDID
Regulation Number
862.3280
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 I

Related devices

Category: Pseudocholinesterase IVD, control

Other devices from Siemens Healthcare Diagnostics Inc.

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Properties

  • Contains Latex
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Microbial Substances: 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