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N/A 340991

by Becton, Dickinson and Company

Ref 340991

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 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038290BKWKCPLI92 Basic UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00382903409914 UDI-DIDate8 Jun 2016ListedStatusListed 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  • Withdrawn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
Not Applicable
Generic Name
Multiple CD cell marker IVD, control
Model / Ref / Catalog
340991
Primary DI / UDI-DI
00382903409914
Basic UDI-DI
038290BKWKCPLI92
FDA Product Code
GGL
EMDN Code
W0103080404 Stem cell enumeration controls
GMDN Term
Multiple CD cell marker IVD, control
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
864.8625
Market of Registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class II

Related devices

Category: Multiple CD cell marker IVD, control

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Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (14)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No