Skip to content

Agilon® 78010195

by implantcast GmbH

Ref 78010195Model SH11CRIINST

Agilon® 78010195 is a Class I device made by implantcast GmbH, registered in EUDAMED on 13 Aug 2026 (Basic UDI-DI 4048844SH11CRIINST2K) and listed in FDA GUDID since 25 Jun 2024 (UDI-DI 04048844624941), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048844SH11CRIINST2K Basic UDI-DI 04048844624941UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844624941 UDI-DI Date25 Jun 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048844SH11CRIINST2K registered 13 Aug 2026 Active
  • FDA GUDID UDI-DI 04048844624941 listed 25 Jun 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048844624941
  2. Registered EUDAMED 4048844SH11CRIINST2K

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  • Withdrawn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®
Generic name
Orthopaedic inorganic implant inserter/extractor, reusable
Model / reference
78010195, SH11CRIINST
Primary DI / UDI-DI
04048844624941
Basic UDI-DI
4048844SH11CRIINST2K
Direct marketing DI
04048844624941
FDA product code
HWB
EMDN code
L091101 Orthopaedic prostheses and traumatological implants extractors, reusable
GMDN term
Orthopaedic inorganic implant inserter/extractor, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic inorganic implant inserter/extractor, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES AND TRAUMATOLOGICAL IMPLANTS EXTRACTORS, REUSABLE.

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)