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Coded reagent tray for slides with 50 fields ZZ 9999-0150-13-R

by EUROIMMUN Medizinische Labordiagnostika AG

Ref ZZ 9999-0150-13-RModel ZZ 9999-13-R

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 Number4049016ZZ999913RZ8 Basic UDI-DI 04049016152132UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049016152132 UDI-DI Date11 May 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  • Withdrawn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

Trade Name
Coded reagent tray for slides with 50 fields
Generic Name
Assay container IVD, single-use
Model / Reference
ZZ 9999-0150-13-R, ZZ 9999-13-R
Primary DI / UDI-DI
04049016152132
Basic UDI-DI
4049016ZZ999913RZ8
FDA Product Code
LXG
EMDN Code
W05039080 Devices for samples analyses - other accessories
GMDN Term
Assay container IVD, single-use
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
862.2050
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 I

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Properties

  • Professional Testing
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

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
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No