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Hair transplant guide device

by OHDAE Corporation South Korea EUDAMED

Ref ODSI-08 EMDN K01020114

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800181200167 Basic UDI-DIDate21 Dec 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Hair transplant guide device
Model / Reference
ODSI-08
Primary DI / UDI-DI
08800181200167
Basic UDI-DI
B-08800181200167
EMDN Code
K01020114 Minimally invasive surgery guides, single-use
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000025038
Authorised representative
AeMi World e.K DE-AR-000007704

Other devices from OHDAE Corporation

See all devices from OHDAE Corporation →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 56a4116a-45e8-459f-814a-170d82c46579 61 fields · synced 23 Oct 2026