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abioSCOPE Control

by Abionic SA

Ref P02.00045

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 Number7649996894P02A1NL Basic UDI-DI 07649996894106UDI-DIDate29 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07649996894106 UDI-DI Date29 Sep 2025ListedStatusListed 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  • Withdrawn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

Generic Name
Immunoassay instrument/analyser general performance control kit IVD
Model / Reference
P02.00045
Primary DI / UDI-DI
07649996894106
Basic UDI-DI
7649996894P02A1NL
FDA Product Code
JJX
EMDN Code
W0102160801 Controls immunochem - rt & poc
GMDN Term
Immunoassay instrument/analyser general performance control kit IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
862.1660
EU market of registration
Greece
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
CH-MF-000026307
Authorised representative
Veranex Germany GmbH DE-AR-000005578

Other devices from Abionic SA

Properties

  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing
  • New Device
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (14)

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