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N/A Xd 8002

by Ulrich GmbH & Co. KG

Ref XD 8002Model Pump tubing incl. Spikes für flex tubing

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

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
European UnionCE/MDR EUDAMED Number4052536000041PS Basic UDI-DI 04052536184514UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04052536184514 UDI-DI Date12 Mar 2019ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
ulrich medical disposables
Generic Name
Electric infusion pump administration set, reusable
Model / Ref / Catalog
XD 8002, Pump tubing incl. Spikes für flex tubing
Primary DI / UDI-DI
04052536184514
Basic UDI-DI
4052536000041PS
510(k) Number
FDA Product Code
IZQ
EMDN Code
A03010105 Infusion pump controllers
GMDN Term
Electric infusion pump administration set, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1650
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Electric infusion pump administration set, reusable

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Cleared under the same submission (K251295)

Other devices from Ulrich GmbH & Co. KG

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Properties

  • Sterile
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No