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Fractomed Lite

by Mondomed NV EUDAMED

Active European Union

Ref 1055818AL, 1055850LL, 1055796LL, 1055812LR, 1055799LL, 1055817AL, 1055780LL, 1055799LR, 1055810LL, 1055798LR, 1055840LR, 1055779LR, 1055779LL, 1055839LR, 1055796LR, 1055839LL, 1055781LR, 1055698LL, 1055780LR, 1055697LR, 1055678LR, 1055816L, 1055807L, 1055791LR, 1055820L, 1055697LL, 1055782LL, 1055699LR, 1055809L, 1055791LL, 1055692LR, 1055781LL, 1055692LL, 1055793LL, 1055693LR, 1055797LL, 1055795LL, 1055841LL, 1055794LR, 1055772LL, 1055812LL, 1055792LL, 1055813LR, 1055819, 1055785, 10558171, 1044758, 1055805, 1055864, 1055773, 1044705Model splinting devices

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number542502543fractomedS4 Basic UDI-DIDate16 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Trade Name
Fractomed Lite
Fractomed
Model / Reference
splinting devices, 1055818AL, 1055850LL, 1055796LL, 1055812LR, 1055799LL, 1055817AL, 1055780LL, 1055799LR, 1055810LL, 1055798LR, 1055840LR, 1055779LR, 1055779LL, 1055839LR, 1055796LR, 1055839LL, 1055781LR, 1055698LL, 1055780LR, 1055697LR, 1055678LR, 1055816L, 1055807L, 1055791LR, 1055820L, 1055697LL, 1055782LL, 1055699LR, 1055809L, 1055791LL, 1055692LR, 1055781LL, 1055692LL, 1055793LL, 1055693LR, 1055797LL, 1055795LL, 1055841LL, 1055794LR, 1055772LL, 1055812LL, 1055792LL, 1055813LR, 1055819, 1055785, 10558171, 1044758, 1055805, 1055864, 1055773, 1044705
Primary DI / UDI-DI
05425025432677, 05425025432493, 05425025432554, 05425025432127, 05425025432639, 05425025432660, 05425025432028, 05425025432646, 05425025432479, 05425025432622, 05425025432226, 05425025432011, 05425025432004, 05425025432714, 05425025432561, 05425025432707, 05425025432059, 05425025432769, 05425025432035, 05425025432752, 05425025432424, 05425025432158, 05425025432073, 05425025432325, 05425025432462, 05425025432745, 05425025432394, 05425025432790, 05425025432585, 05425025432318, 05425025432738, 05425025432042, 05425025432721, 05425025432332, 05425025432691, 05425025432592, 05425025432530, 05425025432233, 05425025432523, 05425025432356, 05425025432110, 05425025432295, 05425025432141, 05425025430789, 05425025430567, 05425025431366, 05425025431434, 05425025430659, 05425025431069, 05425025430499, 05425025430062
Basic UDI-DI
542502543fractomedS4
EMDN Code
M030504 Immobilisation systems, mouldable under cold and hot temperatures
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000001283

Other devices from Mondomed NV

See all devices from Mondomed NV →

Properties

Show 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