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BN II System 11539176

by Siemens Healthcare Diagnostics Products Ltd United States EUDAMEDGUDID

Ref 11539176Model IVDR_27_MAR EB_A_INST_BNII Product code DEWEMDN W0201020204

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00630414655598 UDI-DIDate15 Sep 2026ListedStatusIn distribution
European UnionCE/IVDR EUDAMED Number0405686900856W6 Basic UDI-DIDate9 Jul 2026RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
BN II System
Generic Name
Nephelometry immunoassay analyser IVD
Device Name
IVDR_27_MAR Eb_a_inst_bnii
Model / Ref / Catalog
11539176, IVDR_27_MAR EB_A_INST_BNII
Primary DI / UDI-DI
00630414655598
Basic UDI-DI
0405686900856W6
510(k) Number
FDA Product Code
DEW
EMDN Code
W0201020204 Nephelometers
GMDN Term
Nephelometry immunoassay analyser IVD
Device Class
Class A EUDAMED
Class II GUDID
Regulation Number
866.5510
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class II

Related devices

Cleared under the same submission (K943997)

Other devices from Siemens Healthcare Diagnostics Products Ltd

See all devices from Siemens Healthcare Diagnostics Products Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
  • Serial Number
Other properties (21)
  • 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
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (2)

  • FDA UDI b4bee67a-dd22-432c-a1df-3ec4dc1b815f 36 fields · synced 24 Oct 2026
  • EUDAMED 00630414655598|0405686900856W6 61 fields · synced 24 Oct 2026