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Craniofacial bone distractor system component multiple use

by Synthes GmbH 12 variants

Ref 387.424, 314.404, 03.315.003, 03.307.010, 394.990, 395.101, 314.003, 314.408, 03.509.002, 314.407, 03.315.001, 03.509.003Model Craniofacial bone distractor system component multiple use

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7611819a00016HX Basic UDI-DI Date11 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Craniofacial bone distractor system component multiple use
Model / Reference
Craniofacial bone distractor system component multiple use, 387.424, 314.404, 03.315.003, 03.307.010, 394.990, 395.101, 314.003, 314.408, 03.509.002, 314.407, 03.315.001, 03.509.003
Primary DI / UDI-DI
07611819713338, 07611819743687, 07611819947702, 07611819809109, 07611819700260, 07611819743694, 07611819169203, 07611819809239, 07611819337060, 07611819809222, 07611819947696, 07611819337077
Basic UDI-DI
7611819a00016HX
Direct Marketing DI
07611819713338
07611819743687
07611819947702
07611819809109
07611819743694
07611819169203
07611819809239
07611819337060
07611819809222
07611819947696
07611819337077
EMDN Code
L091001, P09120499
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

  • CMR Substance NoEUDAMEDYesEUDAMED

Other properties (12)

  • Sterile: No
  • Implantable: No
  • 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