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Capsule Dome G-Tube 9-CG2420-I

by Applied Medical Technology, Inc. EUDAMEDGUDID

Active European Union

Ref 9-CG2420-I

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08420711DOMEGTUBE3K Basic UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842071133818 UDI-DIDate16 Aug 2024ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Capsule Dome - Pre-Loaded Replacement Gastrostomy Tube EUDAMED
Capsule Dome G-Tube GUDID
Generic Name
Gastrostomy tube
Model / Ref / Catalog
9-CG2420-I
Primary DI / UDI-DI
00842071133818
Basic UDI-DI
08420711DOMEGTUBE3K
510(k) Number
FDA Product Code
KNT
EMDN Code
G02020201 Gastrostomy, tubes and sets
GMDN Term
Gastrostomy tube
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.5980
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Catheter Gauge — 24 French

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Gastrostomy tube

Cleared under the same submission (K043027)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No