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Atellica HEMA Slidemaker Stainer (SMS)

by Siemens Healthcare Diagnostics Inc.

Ref 11315459Model IVDR_27_TTN_DUB-C_A_INST_SMS

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number0405686902203UZ Basic UDI-DI 00630414289700UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414289700 UDI-DI Date6 Feb 2026ListedStatusListed 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.

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  • Withdrawn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
Microscope slide maker/stainer IVD
Device Name
IVDR_27_TTN_DUB-C_a_inst_sms
Model / Ref / Catalog
IVDR_27_TTN_DUB-C_A_INST_SMS, 11315459
Primary DI / UDI-DI
00630414289700
Basic UDI-DI
0405686902203UZ
FDA Product Code
KPA
EMDN Code
W0202010180 Automated whole blood hematology analysers - hardware accessories
GMDN Term
Microscope slide maker/stainer IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.3800
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class I

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

  • Professional Testing
  • Surgical Instrument
  • Premarket Exempt
  • Serial Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No