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GH Innotek

by GH Innotek Co., Ltd. South Korea EUDAMED

Ref 08800112500007 EMDN R900902

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88001125IMTPEPJT Basic UDI-DIDate12 Aug 2024RegisteredStatusActive

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  • Withdrawn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 · synced 22 Oct 2026

Device Name
Double Action IMT/PEP
Model / Reference
08800112500007
Primary DI / UDI-DI
08800112500007
Basic UDI-DI
88001125IMTPEPJT
Direct Marketing DI
08800112500007
EMDN Code
R900902 Inspiratory and expiratory flow stimulators/respiratory muscles trainers
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
KR-MF-000039207
Authorised representative
MYM SOPORTE TECNICO Y DE CALIDAD, S.L. ES-AR-000017300

Other devices from GH Innotek Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 2ae567d4-6e32-4281-b0fe-75cd121fbedd 61 fields · synced 22 Oct 2026