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Syva® Emit® II Plus Methaqualone Assay 10445475

by Siemens Healthcare Diagnostics Inc.

Ref 10445475Model IVDR_67_GLA_DUB-C_B_REAG_Methaqualone Assay

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

CE IVDR

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/IVDR EUDAMED Number0405686901149VD Basic UDI-DI 00842768002212UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768002212 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  • Withdrawn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/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Emit II Plus Methaqualone Assay EUDAMED
Syva® Emit® II Plus Methaqualone Assay GUDID
Generic Name
Methaqualone IVD, kit, enzyme immunoassay (EIA)
Device Name
IVDR_67_GLA_DUB-C_B_REAG_Methaqualone Assay
Model / Ref / Catalog
10445475, IVDR_67_GLA_DUB-C_B_REAG_Methaqualone Assay, 9Q129UL
Primary DI / UDI-DI
00842768002212
Basic UDI-DI
0405686901149VD
510(k) Number
FDA Product Code
KXS
EMDN Code
W0102090111 Methaqualone
GMDN Term
Methaqualone IVD, kit, enzyme immunoassay (EIA)
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
862.3630
EU 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

Related devices

Category: Methaqualone IVD, kit, enzyme immunoassay (EIA)

Cleared under the same submission (K993986)

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