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Syva® Emit® Caffeine Control 10445372

by Siemens Healthcare Diagnostics Inc.

Ref 10445372Model IVDR_67_GLA_DUB-C_C_REAG_Caffeine Control

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 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686901070UX Basic UDI-DI 00842768001420UDI-DIDate17 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768001420 UDI-DI Date24 Sep 2020ListedStatusListed 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 24 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  • Withdrawn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 Caffeine Control EUDAMED
Syva® Emit® Caffeine Control GUDID
Generic Name
Caffeine IVD, control
Device Name
IVDR_67_GLA_DUB-C_C_REAG_Caffeine Control
Model / Ref / Catalog
10445372, IVDR_67_GLA_DUB-C_C_REAG_Caffeine Control, 6P499UL
Primary DI / UDI-DI
00842768001420
Basic UDI-DI
0405686901070UX
510(k) Number
FDA Product Code
LAS
EMDN Code
W0102152009 Controls for narcotics / toxicology
GMDN Term
Caffeine IVD, control
Device Class
Class C 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 C
GUDID
Class I

Related devices

Category: Caffeine IVD, control

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

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

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Animal Tissues: 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