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AGILON® trial stem 78512016

by implantcast GmbH

Part of a family of 64 devices: see the family page

Ref 78512016Model SH12TSINST

AGILON® trial stem 78512016 is a device classified as Class IIa in the EU and Class II in the US made by implantcast GmbH, registered in EUDAMED on 13 Aug 2026 (Basic UDI-DI 4048844SH12TSINSTSF) and listed in FDA GUDID since 19 Nov 2020 (UDI-DI 04048844333331), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048844SH12TSINSTSF Basic UDI-DI 04048844333331UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844333331 UDI-DI Date19 Nov 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048844SH12TSINSTSF registered 13 Aug 2026 Active
  • FDA GUDID UDI-DI 04048844333331 listed 19 Nov 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048844333331
  2. Registered EUDAMED 4048844SH12TSINSTSF

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  • Withdrawn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® trial stem GUDID
Generic name
Humeral stem prosthesis trial, reusable
Model / reference
78512016, SH12TSINST
Primary DI / UDI-DI
04048844333331
Basic UDI-DI
4048844SH12TSINSTSF
Direct marketing DI
04048844333331
FDA product code
HSD, PHX
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Humeral stem prosthesis trial, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3690, 888.3660
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Humeral stem prosthesis trial, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Lot / batch number
Other properties (22, all answered No)