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AGILON® CTA trial cap 78204417

by implantcast GmbH

Ref 78204417Model SH12CTCINST

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048844SH12CTCINSTZT Basic UDI-DI 04048844230425UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844230425 UDI-DI Date19 Nov 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  • Withdrawn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
Agilon® EUDAMED
AGILON® CTA trial cap GUDID
Generic Name
Humeral head prosthesis trial, reusable
Model / Reference
78204417, SH12CTCINST
Primary DI / UDI-DI
04048844230425
Basic UDI-DI
4048844SH12CTCINSTZT
FDA Product Code
HSD, PHX
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN Term
Humeral head prosthesis trial, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3690, 888.3660
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Humeral head prosthesis trial, reusable

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

Properties

  • Lot / Batch Number

Other properties (23)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No