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EsophyX® Z+ A

by Merit Medical Systems, Inc.

Ref R2007

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

CE MDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884450BUDI762QG Basic UDI-DI 00884450097076UDI-DIDate15 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450097076 UDI-DI Date14 Jan 2026ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
EsophyX® Z+
Generic Name
Gastro-oesophageal antireflux fundal implant placement tool, single-use
Device Name
EsophyX Z+ Device
Model / Ref / Catalog
R2007, A
Primary DI / UDI-DI
00884450097076 EUDAMED
00884450848111 GUDID
Basic UDI-DI
0884450BUDI762QG
FDA Product Code
ODE
EMDN Code
G030899 Instruments for gastro-intestinal endoscopy and eco-endoscopy, single-use - other
GMDN Term
Gastro-oesophageal antireflux fundal implant placement tool, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
R2007
GUDID
A
Primary DI / UDI-DIEUDAMED
00884450097076
GUDID
00884450848111
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Animal Tissues
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human 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
  • Manufacturing Date: No