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Agilon®

by implantcast GmbH 95 variants

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

Ref 78001216Model SH12TSINST

Agilon® (78001216) is a Class IIa device made by implantcast GmbH, registered in EUDAMED on 13 Aug 2026 (Basic UDI-DI 4048844SH12TSINSTSF), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4048844SH12TSINSTSF Basic UDI-DI 04048844194499UDI-DIDate13 Aug 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
SH12TSINST, 78001216
Primary DI / UDI-DI
04048844194499
Basic UDI-DI
4048844SH12TSINSTSF
Direct marketing DI
04048844194499
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000010002

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)
Other properties (12, all answered No)