Skip to content

External orthopaedic fixation system component multiple use

by Synthes GmbH 104 variants

Ref 394.830, 392.770, 393.420.10, 03.311.110, 394.080, 393.540, 03.311.880, 03.311.125, 393.760, 393.530, 03.311.846, 395.105, 03.311.948, 390.004, 393.600, 390.032, 03.311.012, 390.034, 03.311.312, 03.311.106, 03.311.070, 393.620, 392.903, 394.900, 03.311.062, 390.006, 390.008, 392.905, 392.943, 03.311.230, 392.913, 393.510, 393.500, 392.938, 03.311.392, 390.002, 03.311.135, 03.311.986, 394.870, 393.550, 03.311.375, 03.311.451, 392.360, 392.720, 03.311.810, 393.970, 03.311.050, 03.306.000, 392.942, 03.311.878, 03.311.059Model External orthopaedic fixation 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 Number7611819a00014HT Basic UDI-DI Date8 Sep 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  • Withdrawn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
External orthopaedic fixation system component multiple use
Model / Reference
External orthopaedic fixation system component multiple use, 394.830, 392.770, 393.420.10, 03.311.110, 394.080, 393.540, 03.311.880, 03.311.125, 393.760, 393.530, 03.311.846, 395.105, 03.311.948, 390.004, 393.600, 390.032, 03.311.012, 390.034, 03.311.312, 03.311.106, 03.311.070, 393.620, 392.903, 394.900, 03.311.062, 390.006, 390.008, 392.905, 392.943, 03.311.230, 392.913, 393.510, 393.500, 392.938, 03.311.392, 390.002, 03.311.135, 03.311.986, 394.870, 393.550, 03.311.375, 03.311.451, 392.360, 392.720, 03.311.810, 393.970, 03.311.050, 03.306.000, 392.942, 03.311.878, 03.311.059
Primary DI / UDI-DI
07611819025936, 07611819025080, 07611819322066, 07611819872615, 07611819200012, 07611819025349, 07611819873292, 07611819872653, 07611819025455, 07611819025332, 07611819873223, 07611819200029, 07611819873414, 07611819760578, 07611819025400, 07611819784161, 07611819872387, 07611819784185, 07611819872806, 07611819872592, 07611819872516, 07611819025424, 07611819083721, 07611819026001, 07611819872509, 07611819758421, 07611819760592, 07611819083714, 07611819094093, 07611819872745, 07611819087897, 07611819025318, 07611819025301, 07611819091856, 07611819873001, 07611819760554, 07611819872677, 07611819411579, 07611819025974, 07611819025356, 07611819872950, 07611819873087, 07611819024908, 07611819025066, 07611819873100, 07611819025578, 07611819872455, 07611819791374, 07611819093652, 07611819873285, 07611819411418
Basic UDI-DI
7611819a00014HT
Unit of Use DI
87611819322062
Direct Marketing DI
07611819025936
07611819025080
07611819200012
07611819025349
07611819873292
07611819025455
07611819025332
07611819873223
07611819200029
07611819873414
07611819760578
07611819025400
07611819784161
07611819872387
07611819784185
07611819872806
07611819872516
07611819025424
07611819083721
07611819026001
07611819872509
07611819758421
07611819760592
07611819083714
07611819094093
07611819872745
07611819087897
07611819025318
07611819025301
07611819091856
07611819873001
07611819760554
07611819411579
07611819025974
07611819025356
07611819872950
07611819873087
07611819025066
07611819873100
07611819791374
07611819093652
07611819873285
07611819411418
EMDN Code
P0912040102, L0999
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

Other properties (13)

  • Sterile: No
  • 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