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Ennovate®

by Aesculap AG 9 variants

Ref SY818TS, SY544TS, SY331TS, SY1364TS, SY983KS, SY334TS, SY1256TS, SY023TS, SZ013SU, SY011TS, SY376TS, SY556TS, SY1231TS, SY1222TS, SY806TS, SY812TS, SY269TS, SY1379TS, SZ091R, SY278TS, SY392TS, SY1266TS, SY337TS, SY484KS, SY351TS, SY455KS, SY275TS, SY963KS, SY982KS, SY233TS, SY025TS, SY1312TS, SY399TS, SY577TS, SY1399TS, SZ081R, SY545TS, SY1325TS, SY469KS, SY021TS, SY1248TS, SY053TS, SY520TS, SY557TS, SY323TS, SY467KS, SY566TS, SY562TS, SY815TS, SY221TS, SY991KS

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 Number40392390000026793J Basic UDI-DI Date15 Sep 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  • Withdrawn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
ENNOVATE spinal system implant III
ENNOVATE implant, sterile
ENNOVATE C instrument IIa SU sterile
ENNOVATE C Instrument IIa RU
Model / Reference
SY818TS, SY544TS, SY331TS, SY1364TS, SY983KS, SY334TS, SY1256TS, SY023TS, SZ013SU, SY011TS, SY376TS, SY556TS, SY1231TS, SY1222TS, SY806TS, SY812TS, SY269TS, SY1379TS, SZ091R, SY278TS, SY392TS, SY1266TS, SY337TS, SY484KS, SY351TS, SY455KS, SY275TS, SY963KS, SY982KS, SY233TS, SY025TS, SY1312TS, SY399TS, SY577TS, SY1399TS, SZ081R, SY545TS, SY1325TS, SY469KS, SY021TS, SY1248TS, SY053TS, SY520TS, SY557TS, SY323TS, SY467KS, SY566TS, SY562TS, SY815TS, SY221TS, SY991KS
Primary DI / UDI-DI
04046955054978, 04046964988127, 04046955226146, 04046955230532, 04046955204922, 04046955226207, 04046955229253, 04046964988530, 04046955181292, 04046964988455, 04046955227167, 04046964988233, 04046955228874, 04046955228768, 04046955054732, 04046955054855, 04046955225217, 04046955230709, 04046955183197, 04046955225798, 04046955227235, 04046955229390, 04046955226269, 04046955204533, 04046955226917, 04046955204304, 04046955225767, 04046955204786, 04046955204915, 04046955224760, 04046964988554, 04046955229598, 04046955227280, 04046964988400, 04046955230792, 04046955183142, 04046964988134, 04046955229895, 04046955204441, 04046964988516, 04046955229185, 04046964988783, 04046964987922, 04046964988240, 04046955226047, 04046955204427, 04046964988318, 04046964988271, 04046955054916, 04046955224609, 04046955205004
Basic UDI-DI
40392390000026793J, 40392390000012962P, 40392390000026252T, 40392390000010792D
Direct Marketing DI
04046955054978
04046955054732
04046955054855
04046955183197
04046955183142
04046955054916
EMDN Code
P09070302, P09070304, P091303, L091199
Device Class
Class III
Class IIb
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005504

Related devices

Category: Spinal bone screw, non-bioabsorbable

Other devices from Aesculap AG

See all devices from Aesculap AG →

Properties

  • Sterile YesEUDAMEDNoEUDAMED
  • Implantable YesEUDAMEDNoEUDAMED
  • Sutures
  • CMR Substance NoEUDAMEDYesEUDAMED

Other properties (10)

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