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Hydroset

by Stryker Leibinger GmbH & Co.KG 3 variants

Ref 397028

Hydroset (397028) is a Class IIa device made by Stryker Leibinger GmbH & Co.KG, registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-37613154888154), active as of 8 Nov 2026.

Active European Union

CE MDD

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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-37613154888154 Basic UDI-DI 37613154888154UDI-DIDate2 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
HydroSet 8GAX10CM Ten Cannulae Curved Pack
Model / reference
397028
Primary DI / UDI-DI
37613154888154
Basic UDI-DI
B-37613154888154
EMDN code
P099002 Orthopaedic cement preparation and application devices and kits
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005522

Similar devices in this category

Other devices filed under ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS.

Other devices from Stryker Leibinger GmbH & Co.KG

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Properties

  • Supplied sterile
Other properties (13, all answered No)