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Atellica CH Ethanol (EtohC)

by Siemens Healthcare Diagnostics Inc.

Ref 11701330Model IVDR_67_TTN_DUB-C_B_REAG_ETOH

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686901708VV Basic UDI-DI 00630414654089UDI-DIDate9 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414654089 UDI-DI Date15 Oct 2025ListedStatusListed 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

1 recall · FDA

    • Terminated Z-1599-2020 FDA Class II initiated 14 Feb 2020

    The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.

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  • Withdrawn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

Generic Name
Ethanol (ETOH) IVD, kit, spectrophotometry
Device Name
IVDR_67_TTN_DUB-C_b_reag_etoh
Model / Ref / Catalog
IVDR_67_TTN_DUB-C_B_REAG_ETOH, 11701330
Primary DI / UDI-DI
00630414654089
Basic UDI-DI
0405686901708VV
Unit of Use DI
00630414321981
510(k) Number
FDA Product Code
DIC
EMDN Code
W0102090207 Ethanol (alcohol)
GMDN Term
Ethanol (ETOH) IVD, kit, spectrophotometry
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
862.3040
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

Manufacturer details

EUDAMED SRN
US-MF-000016560
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

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

Other properties (19)

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