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ZepHr

by Diversatek Healthcare United States EUDAMEDGUDID

Ref A04-2000-S

Product code FFXEMDN Z120704

Regulatory status

as of 25 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081673402Z07DY Basic UDI-DIDate29 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00816734021675 UDI-DIDate24 Sep 2016ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2521-2023 FDA Class III initiated 25 Jul 2023

    GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.

    • Terminated Z-1487-2012 FDA Unclassified (pre-2012) initiated 23 Feb 2009

    Software error may produce incorrect esophageal contraction readings.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
ZepHr EUDAMED
Diversatek Healthcare GUDID
Generic Name
Manometric gastrointestinal motility analysis system
Device Name
ZepHr Reflux Monitoring System
Model / Ref / Catalog
A04-2000-S
Primary DI / UDI-DI
00816734021675
Basic UDI-DI
081673402Z07DY
Direct Marketing DI
00816734021675
510(k) Number
FDA Product Code
FFX
EMDN Code
Z120704 Gastric ph monitor
GMDN Term
Manometric gastrointestinal motility analysis system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1725
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000025177
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Diversatek Healthcare

See all devices from Diversatek Healthcare →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
Other properties (22)
  • Sterile: No
  • 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
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED 688930d6-d3fb-42dc-a420-222ade8cc377 61 fields · synced 22 Oct 2026
  • FDA UDI 3e7b21a6-518f-4c3e-99e1-e2494520fb9d 36 fields · synced 30 May 2026