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AGILON® assembling block 78010021

by implantcast GmbH

Ref 78010021Model SH15ABINST

AGILON® assembling block 78010021 is a Class I device made by implantcast GmbH, registered in EUDAMED on 13 Aug 2026 (Basic UDI-DI 4048844SH15ABINSTEG) and listed in FDA GUDID since 30 Aug 2022 (UDI-DI 04048844229566), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048844SH15ABINSTEG Basic UDI-DI 04048844229566UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844229566 UDI-DI Date30 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048844SH15ABINSTEG registered 13 Aug 2026 Active
  • FDA GUDID UDI-DI 04048844229566 listed 30 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048844229566
  2. Registered EUDAMED 4048844SH15ABINSTEG

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  • Withdrawn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® assembling block GUDID
Generic name
Orthopaedic implant/instrument assembling device
Model / reference
78010021, SH15ABINST
Primary DI / UDI-DI
04048844229566
Basic UDI-DI
4048844SH15ABINSTEG
Direct marketing DI
04048844229566
FDA product code
LXH
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic implant/instrument assembling device
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Türkiye
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implant/instrument assembling device

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
  • Reusable
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)