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Orthopaedic Tightener/Tensioner and Cerclage Devices

by Synthes GmbH 10 variants

Ref 03.221.004, 391.090, 391.883, 391.130, 391.820, 03.221.010Model Orthopaedic Tightener/Tensioner and Cerclage Devices

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 Number7611819a00107J3 Basic UDI-DI Date11 Jul 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  • Withdrawn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
Orthopaedic Tightener/Tensioner and Cerclage Devices
Model / Reference
Orthopaedic Tightener/Tensioner and Cerclage Devices, 03.221.004, 391.090, 391.883, 391.130, 391.820, 03.221.010
Primary DI / UDI-DI
07611819880078, 07611819024595, 07611819719842, 07611819024618, 07611819024731, 07611819880092
Basic UDI-DI
7611819a00107J3
Direct Marketing DI
07611819880078
07611819024595
07611819719842
07611819024618
07611819024731
07611819880092
EMDN Code
L0999, L091001, L01041202
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
CH-MF-000013345
Authorised representative
DePuy Ireland UC IE-AR-000009328

Other devices from Synthes GmbH

See all devices from Synthes GmbH →

Properties

  • Reusable
  • CMR Substance YesEUDAMEDNoEUDAMED

Other properties (11)

  • Sterile: No
  • Implantable: 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