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Epithelial Membrane Antigen GP1.4 7 mL

by Leica Biosystems Newcastle Ltd

Ref PA0035

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 Number50553313EMAGP1000029A Basic UDI-DI 05055331304704UDI-DIDate22 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055331304704 UDI-DI Date26 Mar 2021ListedStatusListed 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  • Withdrawn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
Epithelial Membrane Antigen GP1.4 7 mL EUDAMED
Bond™ GUDID
Generic Name
Epithelial membrane antigen (EMA) IVD, antibody
Device Name
BOND Ready-to-Use Primary Antibody Epithelial Membrane Antigen (GP1.4)
Model / Ref / Catalog
PA0035
Primary DI / UDI-DI
05055331304704
Basic UDI-DI
50553313EMAGP1000029A
Direct Marketing DI
05055331304704
FDA Product Code
NJT
EMDN Code
W01030709 Primary antisera for immunohistology
GMDN Term
Epithelial membrane antigen (EMA) IVD, antibody
Device Class
Class C EUDAMED
Class I GUDID
Regulation Number
864.1860
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class C
GUDID
Class I

Manufacturer details

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

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Properties

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

Other properties (17)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No