Skip to content

Hi-Line Xs

by Aesculap AG 97 variants

Ref GE416R, GE508R, GE512R, GD804R, GE542R, GE718R, GE606R, GE432R, GE515R, GE389R, GE717R, GE437R, GD749R, GE537R, GE719R, GE616R, GE619R, GE635R, GE620R, GD802R, GE412R, GE502SU, GE546R, GD846R, GE548R, GE716R, GE435R, GE608R, GE634R, GE540R, GE531R, GE402R, GE714R, GE607R, GD794R, GE425R, GD696R, GE525R, GE507R, GD692R, GE511R, GE532R, GE504R, GE406R, GE411R, GE390R, GE404R, GE408R, GE419R, GE544R, GE505R

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number40392390000026702Y Basic UDI-DI Date10 Dec 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
Hi-Line Xs
Hi-Line
Device Name
PS-Tools rotating instr. diamond RU
PS-Tools rotating instrument sterile RU
PS-Tools rotating instrument sterile SU
Model / Reference
GE416R, GE508R, GE512R, GD804R, GE542R, GE718R, GE606R, GE432R, GE515R, GE389R, GE717R, GE437R, GD749R, GE537R, GE719R, GE616R, GE619R, GE635R, GE620R, GD802R, GE412R, GE502SU, GE546R, GD846R, GE548R, GE716R, GE435R, GE608R, GE634R, GE540R, GE531R, GE402R, GE714R, GE607R, GD794R, GE425R, GD696R, GE525R, GE507R, GD692R, GE511R, GE532R, GE504R, GE406R, GE411R, GE390R, GE404R, GE408R, GE419R, GE544R, GE505R
Primary DI / UDI-DI
04038653378937, 04038653398300, 04038653378968, 04038653075614, 04038653379415, 04038653469796, 04038653378869, 04038653379309, 04038653378999, 04046963322298, 04038653469789, 04038653379347, 04038653075270, 04038653379354, 04038653469802, 04038653379057, 04038653398393, 04038653379392, 04038653379095, 04038653075591, 04038653378890, 04038653399079, 04038653379439, 04038653279920, 04046963364540, 04038653469772, 04046963129125, 04038653398324, 04038653379385, 04038653379408, 04046963129156, 04038653378708, 04038653469765, 04038653378876, 04038653075515, 04038653379170, 04038653219018, 04038653379194, 04038653378821, 04038653218974, 04038653378951, 04038653379323, 04038653378791, 04038653378746, 04038653378883, 04038653463350, 04038653378722, 04038653398287, 04038653398355, 04038653379422, 04038653378807
Basic UDI-DI
40392390000026702Y, 403923900000267132, 40392390000026753A
EMDN Code
Z12100980 Instruments for motorised neurosurgery systems - hardware accessories
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005504

Other devices from Aesculap AG

See all devices from Aesculap AG →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No