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Procedure Pack

by Europlaz Technologies Ltd. EUDAMEDGUDID

Active European Union

Ref ZX2000

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05060498950343 UDI-DIDate31 Jan 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number506049895ZOG002GK Basic UDI-DIDate22 Oct 2024RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Medicine cup, reusable
Model / Reference
ZX2000
Primary DI / UDI-DI
05060498950343
Basic UDI-DI
506049895ZOG002GK
FDA Product Code
PXA
EMDN Code
A99 Devices for administration, withdrawal and collection - other
GMDN Term
Medicine cup, reusable
Device Class
Class I
Regulation Number
880.6430
Medical Purpose
For the measuring, mixing, storing and oral administration of Active Pharmaceutical Ingredients (APIs)
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
UK-PR-000044280

Other devices from Europlaz Technologies Ltd

Properties

  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No