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N FLC Supplementary Reagent

by Siemens Healthcare Diagnostics Products GmbH

Ref 10873769Model IVDR_27_MAR EB_A_PROF_REAG_N_FLC_Sup

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 23 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00630414312446 UDI-DI Date26 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number0405686900184V8 Basic UDI-DI 00630414312446UDI-DIDate19 Jun 2026RegisteredStatusActive

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 23 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  • Withdrawn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

Generic Name
Kappa/lambda light chain immunoglobulin IVD, reagent
Device Name
IVDR_27_MAR EB_A_PROF_REAG_N_FLC_Sup
Model / Ref / Catalog
IVDR_27_MAR EB_A_PROF_REAG_N_FLC_Sup, 10873769
Primary DI / UDI-DI
00630414312446
Basic UDI-DI
0405686900184V8
510(k) Number
FDA Product Code
DFH, DEH
EMDN Code
W0102010109 Kappa and lambda chain
GMDN Term
Kappa/lambda light chain immunoglobulin IVD, reagent
Device Class
Class A EUDAMED
Class II GUDID
Regulation Number
866.5550
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000005039

Other devices from Siemens Healthcare Diagnostics Products GmbH

See all devices from Siemens Healthcare Diagnostics Products GmbH →

Properties

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

Other properties (19)

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