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Altocast

by Altochem Co., Ltd. EUDAMED

Active European Union

Ref AC536HFC

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88093240410265TY Basic UDI-DIDate11 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Synthetic Orthopedic Cast
Model / Reference
AC536HFC
Primary DI / UDI-DI
08809324043234
Basic UDI-DI
88093240410265TY
EMDN Code
M03050202 Synthetic cast bandages and splints
Device Class
Class I
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
KR-MF-000024602
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Altochem Co., Ltd

See all devices from Altochem Co., Ltd →

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