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Emit® II Plus Benzodiazepine Assay 10445432

by Siemens Healthcare Diagnostics Inc. EUDAMEDGUDID

Active European Union

Ref 10445432Model IVDR_67_GLA_DUB-C_B_REAG_Benzodiazepine Assay

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686901066V8 Basic UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768023392 UDI-DIDate24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Emit® II Plus Benzodiazepine Assay
Generic Name
Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Device Name
IVDR_67_GLA_DUB-C_B_REAG_Benzodiazepine Assay
Model / Ref / Catalog
10445432, IVDR_67_GLA_DUB-C_B_REAG_Benzodiazepine Assay, 9F229
Primary DI / UDI-DI
00842768023392
Basic UDI-DI
0405686901066V8
510(k) Number
FDA Product Code
JXM
EMDN Code
W0102090104 Benzodiazepines
GMDN Term
Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
862.3170
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class II

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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