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Elan 4

by Aesculap AG 409 variants

Ref GE856R, GE891R, GE864TC, GE973TC, GP583R, GE908R, GE912R, GE978TC, GP591R, GP222R, GP542R, GE966TC, GE863TC, GE967TC, GA269SU, GP543SU, GP496SU, GE946R, GE904R, GP491SU, GE910R, GE856TC, GA267SU, GE866TC, GE925R, GE858TC, GE903R, GE936R, GE866R, GE917R, GP223R, GE923R, GE909R, GP373R, GE860TC, GA266SU, GE855R, GP340SU, GP497SU, GP584R, GE937R, GE921R, GE965TC, GP594R, GE962TC, GP544SU, GE970R, GE945R, GP492R, GE895R, GP587R

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number403923900000281634 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  • Withdrawn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

Device Name
2.35 rotating instrument
ELAN 4 saw blade (RU)
ELAN 4 rotating instrument (RU)
ELAN 4 spray nozzle with ring fixation
ELAN 4 saw blade (SU)
ELAN 4 rotating instrument (SU)
Model / Reference
GE856R, GE891R, GE864TC, GE973TC, GP583R, GE908R, GE912R, GE978TC, GP591R, GP222R, GP542R, GE966TC, GE863TC, GE967TC, GA269SU, GP543SU, GP496SU, GE946R, GE904R, GP491SU, GE910R, GE856TC, GA267SU, GE866TC, GE925R, GE858TC, GE903R, GE936R, GE866R, GE917R, GP223R, GE923R, GE909R, GP373R, GE860TC, GA266SU, GE855R, GP340SU, GP497SU, GP584R, GE937R, GE921R, GE965TC, GP594R, GE962TC, GP544SU, GE970R, GE945R, GP492R, GE895R, GP587R
Primary DI / UDI-DI
04046955799381, 04046955802371, 04046955799589, 04046955802944, 04046964776311, 04046955800025, 04046955800063, 04046955802982, 04046964776359, 04046955803002, 04046964527029, 04046955802869, 04046955799572, 04046955802876, 04046964526114, 04046955157518, 04046955157068, 04046955800247, 04046955799992, 04046955156962, 04046955800049, 04046955799510, 04046964526107, 04046955799602, 04046955800162, 04046955799534, 04046955799985, 04046955800209, 04046955799466, 04046955800117, 04046955803026, 04046955800155, 04046955800032, 04046955803064, 04046955799541, 04046964525889, 04046955799374, 04046955803057, 04046955157082, 04046964776328, 04046955800216, 04046955800148, 04046955802852, 04046964776366, 04046955802821, 04046955157532, 04046955802906, 04046955800230, 04046964526961, 04046955802395, 04046964776335
Basic UDI-DI
403923900000281634, 40392390000014592T, 40392390000014572P, 40392390000014642L, 40392390000014602C, 40392390000014582R
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