Skip to content

andorate® Auxiliary Water Connector GAR027

by GA Health Company Limited

Ref GAR027

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number489710695GAR027FN Basic UDI-DI Date18 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04897106950508 UDI-DI Date28 May 2020ListedStatusListed 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  • Withdrawn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
andorate® Auxiliary Water Connector EUDAMEDGUDID
Auxiliary Water Connector EUDAMED
Generic Name
Endoscopic insufflation tubing set, single-use
Model / Reference
GAR027
Primary DI / UDI-DI
04897106950508, 04897106958986
Basic UDI-DI
489710695GAR027FN, 489710695101027SJ
FDA Product Code
OCX
EMDN Code
G030899 Instruments for gastro-intestinal endoscopy and eco-endoscopy, single-use - other
GMDN Term
Endoscopic insufflation tubing set, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from GA Health Company Limited

See all devices from GA Health Company Limited →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Manufacturing Date: No