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MicroScan RENOK Disposable D-Inoculator Sets 60 count

by Beckman Coulter Inc.

Ref B1013-5Model B1018-14

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number15099590655549 UDI-DI Date13 Dec 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number15099501MCRENOKP6 Basic UDI-DI 15099590655549UDI-DIDate31 Jan 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
MicroScan RENOK Disposable D-Inoculator Sets 60 count EUDAMED
MicroScan GUDID
Generic Name
General-microorganism antimicrobial susceptibility culture medium IVD
Device Name
MicroScan RENOK Rehydrating/Inoculating System
Model / Reference
B1018-14, B1013-5
Primary DI / UDI-DI
15099590655549
Basic UDI-DI
15099501MCRENOKP6
FDA Product Code
JTC
EMDN Code
W0203010185 Antibiotic susceptibility analysers - consumables
GMDN Term
General-microorganism antimicrobial susceptibility culture medium IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
866.2500
EU market of registration
Ireland
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-000010288
Authorised representative
Beckman Coulter Ireland Inc. IE-AR-000000886

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Properties

  • Single Use
  • Professional Testing
  • Surgical Instrument
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Sterile: 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
  • Serial Number: No