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Softmode

by Zandar Ayakkabi Ltd Sti 130 variants

Ref BOSSABLK37, 2508BEI39, 55301NVY39, BOLLEBLK43, 251002BLK41, 860BLK38, BOSSABLK41, 2512NVY36, 251002BLK43, 2508BEI41, 2505BEI42, 251001BLK36, 2515BLK40, 821BRD39, 19206BLK39, 55302BLK39, 1145BLK38, BOSTONBEI37, BOSSABLK43, 251001BLK38, 55301BLK42, 1905BLK42, 1905BLK43, 862BLK40, 1103BLK39, 860BLK37, 7264202TUP38, BOLLEBLK41, 1103BLK36, 55303NVY39, 55302BLK37, 55303NVY41, 55302BEI41, 55302BLK38, 55302BEI42, 2512NVY40, 1103TAP37, 1905TAP41, 821BRD36, BOSTONBEI40, 2508BLK41, 55301TAP39, BOSSABLK40, 55302BEI40, 1905TAP43, 55303BLK37, 55301BLK36, 55302BEI39, 821BRD40, 861NVY41, 2512NVY37

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8681009SFTMD016J Basic UDI-DI Date17 Oct 2024RegisteredStatusActive

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  • Withdrawn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
Orthopedic Shoe Made of Leather with Removable Insole
Orthopedic Boots Made of Leather with Removable Insole
Model / Reference
BOSSABLK37, 2508BEI39, 55301NVY39, BOLLEBLK43, 251002BLK41, 860BLK38, BOSSABLK41, 2512NVY36, 251002BLK43, 2508BEI41, 2505BEI42, 251001BLK36, 2515BLK40, 821BRD39, 19206BLK39, 55302BLK39, 1145BLK38, BOSTONBEI37, BOSSABLK43, 251001BLK38, 55301BLK42, 1905BLK42, 1905BLK43, 862BLK40, 1103BLK39, 860BLK37, 7264202TUP38, BOLLEBLK41, 1103BLK36, 55303NVY39, 55302BLK37, 55303NVY41, 55302BEI41, 55302BLK38, 55302BEI42, 2512NVY40, 1103TAP37, 1905TAP41, 821BRD36, BOSTONBEI40, 2508BLK41, 55301TAP39, BOSSABLK40, 55302BEI40, 1905TAP43, 55303BLK37, 55301BLK36, 55302BEI39, 821BRD40, 861NVY41, 2512NVY37
Primary DI / UDI-DI
08681009001612, 08681009000592, 08681009000745, 08681009001759, 08681009001339, 08681009002367, 08681009001650, 08681009001995, 08681009001353, 08681009000615, 08681009000462, 08681009001209, 08681009002107, 08681009002305, 08681009001872, 08681009000882, 08681009001780, 08681009001537, 08681009001674, 08681009001223, 08681009000707, 08681009000226, 08681009000233, 08681009002527, 08681009000035, 08681009002350, 08681009002220, 08681009001735, 08681009000004, 08681009001094, 08681009000868, 08681009001117, 08681009000974, 08681009000875, 08681009000981, 08681009002039, 08681009000097, 08681009000295, 08681009002275, 08681009001568, 08681009000530, 08681009000813, 08681009001643, 08681009000967, 08681009000318, 08681009001001, 08681009000646, 08681009000950, 08681009002312, 08681009002466, 08681009002008
Basic UDI-DI
8681009SFTMD016J, 8681009SFTMD026L
EMDN Code
Y063303 Ready-made orthotic shoes
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000039136

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Properties

  • Contains Latex

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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