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Capsule Monarch® G-Tube 9-C2010

by Applied Medical Technology, Inc. EUDAMEDGUDID

Active European Union

Ref 9-C2010

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08420711MONARCHGTUBEHB Basic UDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842071133641 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  • Withdrawn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 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Capsule Monarch® - Pre-Loaded Replacement Gastrostomy Tube EUDAMED
Capsule Monarch® G-Tube GUDID
Generic Name
Gastrostomy tube
Model / Ref / Catalog
9-C2010
Primary DI / UDI-DI
00842071133641
Basic UDI-DI
08420711MONARCHGTUBEHB
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 — 20 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)

Other devices from Applied Medical Technology, Inc.

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Properties

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

Other properties (17)

  • 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