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BOND-PRIME Wash Solution Concentrate

by Leica Biosystems Newcastle Ltd

Ref AR0085

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 Number50553313PRIWAS00005DF Basic UDI-DI 05055331330512UDI-DIDate13 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055331330512 UDI-DI Date7 Dec 2022ListedStatusListed 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  • Withdrawn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
BOND-PRIME Wash Solution Concentrate EUDAMED
Bond-Prime GUDID
Generic Name
Buffered wash solution IVD
Model / Ref / Catalog
AR0085
Primary DI / UDI-DI
05055331330512
Basic UDI-DI
50553313PRIWAS00005DF
Direct Marketing DI
05055331330512
FDA Product Code
PPM
EMDN Code
W0103010199 Reagents for (automated) haematology analyzer - other
GMDN Term
Buffered wash solution IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.4010
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

Manufacturer details

EUDAMED SRN
GB-MF-000020595
Authorised representative
CEpartner4U NL-AR-000000111

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Properties

  • Reagent
  • Professional Testing
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

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